Неделя, 20 Август 2017 г.
новини от последните 24 часа: 771
Лупа
Our client is one of the global integrated pharmaceutical companies, currently expanding its organization and creating a division to support Third Party Operations (TPO). We are looking for an experienced and responsible professional for the position Subject Matter Support Expert to join the TPO division. MISSION OF THE ROLE: The main role of the Subject Matter Support Expert is to support the company’s Quality Third Party Operations (TPO) European team for archiving and sending GMP related documents. RESPONSIBILITIES: • Compiling parts of the Registration Dossier and assigning version numbers • Dispatching approved documentation to the third party manufacturers • Electronic archiving of GMP-relevant documents from contract manufacturers in SAP data base • Archiving of GMP-relevant documents from third party manufacturers (paper versions) • Tracking feedback from third party manufacturers • Handling general office coordination, orders, relocation, administration of office materials, computers, etc. • Regularly evaluating standard metrics (KPIs) REQUIREMENTS AND COMPETENCES: • University Degree in commercial or natural sciences • Minimum 2 years of experience in a commercial/office position • Very good English skills (written and spoken) • Solid knowledge of Word, Excel, SAP and Adobe Writer THE COMPANY OFFERS: • Chance to join a global pharmaceutical company • Professional working environment providing opportunities for development • Competitive remuneration package If you recognize yourself in this position, please send us your CV in English. Only shortlisted candidates will be approached. All applications will be considered under the terms and conditions of confidentiality in accordance with the regulations of personal data protection. Wyser EOOD activities are based on a Recruitment license №2311 issued on 13.07.2017, valid indefinitely.
Обяви за работа
DNB Solutions Ltd., a Business Process Outsourcing service provider based Bulgaria, is looking for a talented and highly motivated Salesforce Developer to join our Sofia Team. The Salesforce Developer works in conjunction with the project Architect to build the technical solution for a client need. Depending on the nature of the project, this role will be required to configure the solution within the Salesforce platform and/or perform custom development, and may be called on to assist with activities like scoping and documentation. The end client that the Salesforce Developer will be working with from our Sofia Office is a US financial institution with over $3 billion assets under management, 100 staff members and 13 current offices in 4 states. Responsibilities will include but will not be limited to:
  • Translate business requirements into well-architected solutions that best leverage the Salesforce platform and products;
  • Participate in technical design sessions; develop technical solution documentation aligned with the business objectives;
  • Develop, test, and document custom development, integrations, and data migration elements of a Salesforce implementation;
  • Develop custom solutions and interfaces on top of the Salesforce platform;
  • Execute test plans to ensure quality delivery;
  • Follow coding standards and participate in code reviews during projects to ensure appropriate design patterns are followed;
  • Provide estimates and work breakdown structures for assigned tasks;
  • Absorb new product and technical capabilities from Salesforce during new product releases and acquisitions;
Обяви за работа
Our client is one of the global integrated pharmaceutical companies, currently expanding its organization and creating a division to support Third Party Operations (TPO). We are looking for an experienced and responsible professional for the position Contract Manufacturing Operations Manager (CMO Manager) to join the TPO division. MISSION OF THE ROLE: The main role of the CMO Manager is to guarantee that current pharmaceutical standards, legal regulations and approved registrations are implemented for the production and the controlling of Third Party manufactured products.  RESPONSIBILITIES: • Supervise the entrusted products through the entire life cycle with regard to pharmaceutical quality. • Take actions needed to guarantee the products quality and compliance: initiation, coordination, supervision and functional assessment of activities that are carried out by the relevant expert team. • Support of qualified persons in tasks or meetings related to critical quality issues to provide a thorough and profound basis for decision-making. • Implement and support projects within the department Quality TPO EU Generics to ensure compliance with internal standards. Close cooperation with qualified persons and Quality Officers as well as responsible company’s departments. • Act as internal and external contact person for all issues concerning the pharmaceutical quality of third party manufactured products.  • Coordinate and control of all Good Manufacturing Practices (GMP) relevant documents with regard to manufacturing process, quality control and quality assurance.  • Interact with Total Productive Maintenance (TPM) and involved departments of the company’s group. • Organize Quality Council Meetings, at defined intervals based on risk with CMOs as part of Business Review Meetings.  • Collate key quality performance metrics agreed with CMOs & trends.  • Collect status of Quality improvement actions (derived from audits, deviation & complaint investigations, risk assessments etc.).  • Provide compliance status with QTA requirements. • Prepare Senior Resource Team meetings.  • Provide quality and performance KPIs, report about audit outcomes and other major quality events / concerns, etc. • Ensure that all changes concerning Module 3 of a dossier are submitted to the authority in collaboration with Total Productive Maintenance (TPM) and RA. • Analyze the pharmaceutical and quality relevant points of a deficiency letter sent by the authorities concerning renewals or variations.  • Manage of the correction of the deficiencies. Creation of statements referring to the deficiencies with reference to the legal regulations and compliance to time limits. • Conduct QA Due Diligence of Existing Contract Manufacturer: - Deviations from the filed registration dossier, deficiencies of the GMP status or other open questions will be negotiated directly in direct contact with the supplier or manufacturer which may result in a Change Control  - Procedures and necessary variations, an ad-hoc audit at the site of the manufacturer or in any other corrective action, based on which quality risk assessment is executed. - Check and approve of Master Documents: CoA, Manufacturing Description, Manufacturing Instruction, Master Batch Record, Stability Schedules, Specifications etc. tol be authorized and forwarded back to the supplier in order to assure regulatory compliance on the supplier’s level • Technical Visits/Audits: - Preparation and realization of national and international technical visits in cooperation with other company’s departments.  - Participation in audits and self-inspections. - Follow up of Audits Corrective Action Preventive Action (CAPA) of Tier 1 and Tier 2 Supplier • Review of Procedure Qualification records (PQRs) • Approval of GMP documents without regulatory impact • QC Documentation: CMO officer ensures the implementation of approved release and shelf life specifications and all corresponding methods by CMO and company’s laboratories. Ensuring the compliance of methods to GMP standards and the dossier.  REQUIREMENTS AND COMPETENCES: • Higher degree in Pharmaceutical/Natural/Engineering science  • At least 4 years proven experience in the Pharmaceutica/Healthcare/Medical Devices/Food&Beverage/ Cosmetics industry • First-hand experience in quality control, analytics, production and/or quality assurance • Knowledge of manufacturing processes and test methods, regulatory requirements and guidelines  • Good command of MS office, SAP and Track Wise • High degree of self-initiative and keen sense of responsibility • Excellent communication skills and very good level of English (written and spoken) • Ability to work well as part of a team • High degree of resilience THE COMPANY OFFERS: • Challenging and interesting position in a multinational company • The opportunity to be part of a brand new structure in the company and set the standard  • Competitive remuneration package • Regular trainings If you recognize yourself in this position, please send us your CV in English. Only shortlisted candidates will be approached. All applications will be considered under the terms and conditions of confidentiality in accordance with the regulations of personal data protection. Wyser EOOD activities are based on a Recruitment license №2311 issued on 13.07.2017, valid indefinitely.
Обяви за работа

Our client is one of the global integrated pharmaceutical companies, currently expanding its organization and creating a division to support Third Party Operations (TPO) on EMEA level. In this regard, we are looking for an experienced and responsible professional for the position MANAGER COMPLIANCE to join the TPO division. MISSION OF THE ROLE: The main role of the Manager Compliance will be to ensure the highest quality of all pharmaceutical products as well as finding all deflections in the laboratory or during the manufacturing process. Previous experience in quality assurance or similar will be considered a strong advantage. RESPONSIBILITIES: • Assuring that the investigation/deviation is performed according to company’s procedures. • Identifying of critical deviations of validated analytical method, qualified analytical apparatus and preparation of facts for the qualified person • Coordinating the root cause study in accordance with quality related deviations (OOS/ Out of Specification results) with the target to prepare a risk assessment and restore the GMP status of the testing process and the field of quality control. • Initiating and leading of case-related project groups from different involved departments • Reconstructing the deviation and identifying of the root cause in accordance with affected departments and/or contract manufacturer. • Categorizing of deviations and, if necessary, taking the decision to put the batches on hold to spend time. • Defining of a Corrective Action Preventive Action (CAPA) regarding scope, responsibility and time line to determine the source of the deviation and chase the implementation. Deviation at the contract manufacturer • Evaluation of deviation reports from contract manufacturer regarding a possible impact of the batch release process in accordance with the QP.  • Responsibility for assuring that all batches were claimed and reservation all its rights that may arise a defect claim, if a manufacturing error was suspected. • Evaluate the investigation report from the supplier and manage the rejection/credit note with the Planning Department Temperature deviation of deliveries to other company’s sites • A risk assessment should be performed according to the stability data.  • Preparation of a deviation report incl. risk assessment or request of a statement from the Business Risk Services • Information of the transportation and logistics unit and request of an investigation report from the forwarder. Additional responsibilities: • Deviation at the incoming goods department: handling of requests from other company’s sites regarding quantity deviations of the deliveries • Participation in customer audits, on-site audits and self-inspection audits  • Training of employees in Track Wise • Organization of data for preparation of NtM (Notifications to the Manager) and QRMB documents. Organization of documents for authorities and initiation of product recall • Initiation of a risk management report and organization of QRMB/QAM/MAC presentations.  • Perform the notification to the management • Follow-up of actions which have been definite at QRMB/QAM/MAC meetings REQUIREMENTS AND COMPETENCES: • Experience in pharmaceutical manufacturing or other related experience in analytical control and regulatory compliance • University degree in Pharmacy, Science, Engineering or similar • Understanding of the drug manufacturing process, also good knowledge of generics and branded pharmaceutical products will be considered as an advantage • Ability to communicate complex issues to affected departments; decision-making and problem solving skills  • 2-4 years of work knowledge as quality assurance officer • Good communicational and interpersonal as well as organizational skills • Good in written and spoken English language  • Proficiency in MS Office, SAP and Track Wise THE COMPANY OFFERS: • Challenging and interesting position in a multinational company • The opportunity to build and implement strategies and have an impact on the business • Competitive remuneration package • Regular trainings If you recognize yourself in this position, please send us your CV in English. Only shortlisted candidates will be approached. All applications will be considered under the terms and conditions of confidentiality in accordance with the regulations of personal data protection. Wyser EOOD activities are based on a Recruitment license №2311 issued on 13.07.2017, valid indefinitely.
Обяви за работа
In our work, we are stirred by the desire to build up long-term relationships with our partners, accepting their challenges with enthusiasm and supporting them in finding successful solutions together. We follow every project with a strong focus on the objective, and with dedication, competence, professionalism and confidentiality, towards both candidates and client companies.  We are well aware how important employment is for every individual, and we believe that the merit of a company is always measured by the potential, talent and value of its people. Our client is well-established and successful international pharmaceutical company with experience in marketing of innovative, high-quality prescription and non-prescription medicines, medical devices and equipment. On behalf of our client we are looking for MEDICAL REPRESENTATIVE, responsible for Varna and the region. This is an opportunity for an ambitious professional who is eager to contribute to the success of an international company, willing to expand her/his knowledge and gain new experience. MAIN RESPONSIBILITIES: • To inform medical professionals about products individually • To organize lectures, meetings and specialist forums • To manage and monitor sales • To work closely with pediatricians and pharmacies • To implement promotional strategies • To ensure achievement of the business targets CANDIDATES PROFILE: • University degree in natural sciences (pharmacy, medicine, bio-medicine, biology, biochemistry or similar) • At least 3 years of previous professional experience • Sales experience in pharmaceutical industry will be considered an advantage • Independence and high degree of reliability • Demonstrate professional and ethical behavior • Strong communication and negotiation skills  • Time-management, work planning and organizational skills are essential for the role. • Excellent knowledge of English • Clear driving license (B category) • Working knowledge of MS Office THE OFFER: • Professional, supportive, dynamic and proactive working environment • Opportunity to join an international pharmaceutical company • Autonomy and flexibility in organization of the work load • Long-term employment contingency • Regular professional training and continuous opportunities for personal and professional development • Competitive salary and substantial bonus package • Modern company car, computer and smart phone • Excellent product portfolio If you recognize yourself in this position, please send us your CV. Only shortlisted candidates will be approached.  
Обяви за работа
We are looking for expanding our team with SENIOR CONSULTANT to join the business and contribute to its success! THE ROLE REQUIRES: - Experience on the B2B arena – selling services; - Projects delivery experience;  - Business acumen and ability to understand and utilize market trends; - Constant, positive and engaging communication on expert, mid, and senior management levels; - Achieving sales results utilizing existing business relations and establishing new corporate partnerships; - Manage independently CRM system, forecasting, reporting, process administration; - Capability to represent ideas in a creative and intriguing written form; - Has experience with attracting and retaining talents; THE IDEAL CANDIDATE:  - Is a mature, responsible and committed professional; - Result oriented, striving towards excellence and overachieving targets; - Demonstrates capacity to multitask, prioritize, manage change;  - Builds trust and communicates on all levels within organizations;  - Disciplined and proactive individual;  - Capable to manage tasks independently and as a team member;  - Charismatic personality OUR PROPOSAL: - Excellent remuneration package and attractive bonus scheme; - Participating in and leading challenging projects in the high-demanded industries on the market; - International environment and culture - Opportunity for professional development in a multinational company;  - Professional trainings with top notch-tools and methodologies; - Central office location; If you recognize yourself in this position, please send us your CV in English. Only shortlisted candidates will be approached.  
Обяви за работа
  • Подпомага дейността на търговския отдел;
  • Осъществява комуникация с партньори и клиенти на компанията;
  • Изготвя оферти, количествено-стойностни сметки и отчети;
  • Приема и обработва поръчки от клиенти, следи за спазването на уговорените срокове;
  • Работи със счетоводно-складова програма;
  • Следи наличности, поръчки към доставчици;
  • Работи с AUTOCAD
  • Издава фактури, окомплектова документацията по сделки, подготвя документи за търгове;
  • Спазва установените във фирмата стандарти и правила на работа;
  • Поддържа добри взаимоотношения с партньорите на фирмата;
  • Пътува по обекти в страната
Обяви за работа
In our work, we are stirred by the desire to build up long-term relationships with our partners, accepting their challenges with enthusiasm and supporting them in finding successful solutions together. We follow every project with a strong focus on the objective, and with dedication, competence, professionalism and confidentiality, towards both candidates and client companies. Our client is an international company providing safety, risk and compliance software solutions which allow organisations to achieve operational excellence, regulatory compliance and reduce risk. They are currently for an experienced professional for the new role of Senior Development Engineer (Back End). Main Responsibilities: • Implementing new features across the products using .NET Technologies. • Working closely with our Principle Developers to build well architected solutions. • Working with Product Managers, Business Analysts, Design Engineers, Development Engineers (Front End), Test Engineers, and Infrastructure Engineers to ensure features are delivered to a high standard. • Providing unit tests to support and validate for any development work undertaken • Contributing to the Development Team’s working practices and technology decisions. • Mentoring and coaching other members of your team to help grow their skill sets. Candidate‘s profile: • At least 5 years’ experience of developing rich web applications using .NET Technologies, C# and JavaScript • Expert-level C#, including experience with the latest .NET Framework • A proven ability to deliver technical features within an enterprise application • Knowledge of key architecture patterns and design patterns • Experience using Source Control, preferably Git • Experience of working in an Agile development team • An understanding of the build process, continuous integration and delivery • Experience in writing unit tests • Good knowledge of English is a must • Bachelor’s degree in Computer Science or other similar discipline The Offer: • Be part of a young team working for UK • Office located in the heart of the city • A positive and dynamic environment • Long-term perspectives and chance to work on new products in the aviation industry • Participate in training programs and tutorials If you recognize yourself in this position, please send us your CV. Only shortlisted candidates will be approached.  All applications will be considered under the terms and conditions of confidentiality in accordance with the regulations of personal data protection. Wyser EOOD activities are based on a Recruitment license №2311 issued on 13.07.2017, valid indefinitely.
Обяви за работа
Our Client:  The Global specialist in energy management and automation, listed by Fortune magazine as one of the world’s most admired companies in 2015. The company develops connected technologies and solutions to manage energy and process in ways that are safe, reliable, efficient and sustainable. The Group invests in R&D in order to sustain innovation and differentiation, with a strong commitment to sustainable development. Job Mission: Sales Manager’s mission is to identify and set up distribution channels, find projects, ensure POS growth and meet sales target in the South Eastern Europe (SEE).   Regular Responsibilities:
  • Cooperate with local team and partner to identify best distribution and POS channels in the market;
  • Identify and recruit suitable distributors and channels;
  • Ensure the SEE market to covered by distributors;
  • Manage customer requests and product position in the SEE market;
  • Establish brand position through website and local marketing documentation. 
Обяви за работа
Our client is one of the global integrated pharmaceutical companies, currently expanding its organization and creating a division to support Third Party Operations (TPO). We are looking for an experienced and responsible professional for the position Subject Matter Support (SMS) Stability Officer to join the TPO division. MISSION OF THE ROLE: The main role of the SMS Stability Officer is to support the planning, organization and evaluation of stability studies (ICH, OGS, raw material tests and other project-related studies). He/she will also support the planning and organization of contract manufacturing operations (CMO) PQRs and stability data from external laboratories, and ensuring a high quality of the company’s products, which comply to national laws and internal guidelines. RESPONSIBILITIES: • Studies performed during stability control: - Requesting stability data from external manufacturers and laboratories - Initiating stability studies in SAP regarding studies performed in other laboratories of the company in collaboration with the involved departments, and regarding external studies - Inputting data from external stability studies in SAP for electronic evaluation - Categorizing results of external stability studies and immediate usage decision so as to keep time lines - Evaluating Out-of-Specification and Out-of-Trend (OOS/OOT) results in collaboration with the stability officer • PQRs: - Providing the stability data for periodic evaluations within the framework of PQRs or key figure surveys - Implementing and tracking of PQR requirements from external manufacturers • Audits/Inspections: - Participating in the preparation of the department for audits and inspections REQUIREMENTS AND COMPETENCES: • University Degree in Pharmacy, Natural Science or a related field • First-hand experience in the field of quality control/quality documentation (preferably with regard to stability testing) • Proficient use of MS Office, and ideally SAP and Business Warehouse  • Very good written and spoken English • Initiative team player with a strong sense of responsibility and stress-resilient • Good communication and presentation skills • Understanding of analytical methods and techniques would be an advantage THE COMPANY OFFERS: • Chance to join a global pharmaceutical company • Professional working environment providing opportunities for development • Competitive remuneration package If you recognize yourself in this position, please send us your CV in English. Only shortlisted candidates will be approached. All applications will be considered under the terms and conditions of confidentiality in accordance with the regulations of personal data protection. Wyser EOOD activities are based on a Recruitment license №2311 issued on 13.07.2017, valid indefinitely.
Обяви за работа
We are looking for an enthusiastic marketing intern to join our marketing department and provide creative ideas to help achieve our goals. You will have administrative and technical duties in developing and implementing marketing strategies. As a marketing intern, you will collaborate with our marketing and sales team in all stages of marketing campaigns.  This internship will help you acquire marketing skills and provide you with knowledge of various marketing strategies. At the end of your internship you will gain broad experience in marketing and will be prepared to enter any work environment. Requirements: -Strong desire to learn and work in a dynamic, fast paced environment -Excellent verbal and written communication skills - Bulgarian and English -Excellent knowledge of MS Office & Google Docs -Basic HTML knowledge -Creative thinking and copywriting skills -Third or fourth year student in related educational program Responsibilities: -Content creation for social media, e-mail, offline promotions, etc. -Develop & execute new ideas for social media campaigns -Monitor social channels for trending news, ideas and memes -Develop relationships and collaborate with our partners (brands, media, restaurants) on social media campaigns -Assist with capturing and analyzing social media metrics -Campaign management support -Prepare marketing presentations Apply: If you are interested in applying for the position, please send us your CV and cover letter via the application form here. Candidates who are deemed suitable for the job will be contacted for an interview. Confidentiality is guaranteed! Good luck! 
Обяви за работа
Our client crafts advanced online gaming software and solutions which power some of the world's top casino operators. The company is growing rapidly through constant innovation, consumer-centric approach and top-notch support. We are looking for someone passionate about sales, traveling all over Europe and meeting new people! If you like how it sounds and you are fluent in English, we welcome the opportunity to learn more about you! What you will do:
  • Market research aimed at identifying selling possibilities
  • Business trips all over Europe – meet and negotiate with new and existing clients
  • Prepare and deliver presentations on products/services
  • Provide offers/contracts to future clients
  • Negotiate/close deals and handle complaints or objections
  • Participate in exhibitions and conferences in Bulgaria and abroad
What you need to have in order to be successful:
  • University Degree
  • 2+ years of related experience
  • Thorough understanding of marketing and negotiating techniques
  • Excellent knowledge of MS Office
  • High personal motivation and a results-driven approach
  • Strong communication skills and high proficiency in English (At least C1)
Why join the company? The Company offers:
  • Fast paced stimulating international environment
  • Competitive salary and benefits combined
  • Dynamic and positive work environment
  • Outstanding career development opportunities
  If you meet the above mentioned criteria, don’t hesitate to apply! We welcome the opportunity to learn more about you!   Please send your CV in English.   Please note that only short-listed candidates will be contacted. License No.1740 valid through 25.06.2019. We will treat your application with full confidentiality!
Обяви за работа
Our mission is to translate our clients’ recruitment needs into projects, creating virtuous circles between valuable candidates who want to grow and companies interested in hiring the best leaders and most promising talents. In our work, we are stirred by the desire to build up long-term relationships with our partners, accepting their challenges with enthusiasm and supporting them in finding successful solutions together. We follow every project with a strong focus on the objective, and with dedication, competence, professionalism and confidentiality, towards both candidates and client companies. We are well aware how important work is for every individual. And we believe that the value of a company is always measured by the potential, talent and value of its people. Our client is a well-established electronics manufacturing and service provider with proven track record and history. The company works with original equipment manufacturers, which are leaders world-wide and are spanning different industries. Due to their continued expansion, we are looking for an experienced professional for the role of PROJECT LEADER. Main responsibilities: • Planning, execution, monitoring and control of the projects. Guaranteeing customer needs satisfaction. • Organizing, controlling and leading the participants in the managed projects. • Supporting the communication within and out of the project team. Liaising with clients, Business Unit Managers, other managers of functional departments etc. • Coordinating internally and communicating with the client during implementation of new processes and products, or changes to already existing ones. • Overseeing financial expenses in accordance with the managed project implementation. • Preparing offers for new projects. Following up on their development. • Initiating and offering specific actions for the improvement of the profit from the products and decreasing the cost price of their production. • Establishing of new processes and products. • Participating in the production analysis by suggesting measures for effectiveness improvement, as well as the selection, requirements and implementation of new equipment. • Initiating the provision of specific tools and instruments. • Coordinating with the Business Unit Manager of the decisions regarding the financial expenses above budget. Requirements: • Higher degree from a Technical University.  • Proficiency in Project Management tools (Gantt charts, risk analysis).  • Knowledge of quality standards will be an advantage. • Good communication and presentation skills. Entrepreneur attitude. • Flexibility, adaptability and high motivation to excel. • Skills to create, organize and lead a team. • Ability to set priorities, follow them, multi-task and work under pressure. • Fluency in English (written and spoken) is a must. Knowledge of a second language (French/German) is a plus. • Computer literacy – excellent Excel skills are mandatory. The company offers: • Challenging and interesting position in a stable and growing company. • Competitive remuneration package. • Participating in and leading challenging projects. • Positive and dynamic working environment. If you find this opportunity interesting and challenging, please send us your CV. Only short listed candidates will be approached.  All applications will be considered under the terms and conditions of confidentiality in accordance with the regulations of personal data protection. Wyser EOOD activities are based on a Recruitment license №2311 issued on 13.07.2017, valid indefinitely.
Обяви за работа
Our mission is to translate our clients’ recruitment needs into projects, creating virtuous circles between valuable candidates who want to grow and companies interested in hiring the best leaders and most promising talents. In our work, we are stirred by the desire to build up long-term relationships with our partners, accepting their challenges with enthusiasm and supporting them in finding successful solutions together. We follow every project with a strong focus on the objective, and with dedication, competence, professionalism and confidentiality, towards both candidates and client companies. We are well aware how important work is for every individual. And we believe that the value of a company is always measured by the potential, talent and value of its people. Our client is a well-established electronics manufacturing and service provider with proven track record and history. The company works with original equipment manufacturers, which are leaders world-wide and are spanning different industries. Due to their continued expansion, we are looking for an experienced professional for the role of TEST DEVELOPMENT TEAM LEADER. Main responsibilities: • Organizing, controlling and coordinating the test developers. • Developing, validating and implementing Functional Test Systems for new systems in compliance with customer and internal requirements. • Participating in the standardization of the Functional Test Systems. • Managing the daily workload of the test development engineers. • Planning and monitoring the performance of the tester development. • Overseeing the Functional Test System development, working closely with other Product team members. • Communicating test specifications with the customer. • Requesting necessary test equipment and complementary electronic parts and modules. • Clarifying all requirements of Test Fixture in close collaboration with responsible Mechanical/Electronic designers. Preparing required input information for Automation department. • Drawing up Test Program in compliance with internal rules. • Running, debugging and validating the ready Test System in production environment. • Writing clear and concise engineering documentation. Guaranteeing the compliance with internal procedures and regulations on every stage of test development. • Collaborating with other Test Managers in the company for test equipment standardization. Requirements: • Higher degree in engineering, preferably in Electronics, Industrial Automation or Computer Science.  • Minimum 2 years of experience in a Test and Development related role, ideally in electronic mass production environment.  • Experience working with measurement and test equipment: oscilloscopes, programmable power • supplies, DAQ Cards, DMMs, source-measure units, LCR meters. • Excellent knowledge of parameters for electronic measurements: familiar with various methods and approaches, and their advantages and disadvantages. • Strong background in design and analysis of electronic schematics and electronic interfaces (I2C, SPI, RS232). • Deep understanding of computer hardware and interfaces: PCI/PCIe, GPIB, RS232, LAN, USB. • Advanced programming skills in C/C++ (LabWindows/CVI) would be a plus. • Excellent communication skills are mandatory. • Fluency in English (written and spoken) is a must. • Team player, results-oriented person with attention to detail. The company offers: • Challenging and interesting position in a stable and growing company. • Competitive remuneration package. • Participating in and leading challenging projects. • Positive and dynamic working environment. If you find this opportunity interesting and challenging, please send us your CV. Only short listed candidates will be approached.  All applications will be considered under the terms and conditions of confidentiality in accordance with the regulations of personal data protection. Wyser EOOD activities are based on a Recruitment license №2311 issued on 13.07.2017, valid indefinitely.
Обяви за работа
Our client is one of the global integrated pharmaceutical companies, currently expanding its organization and creating a new division to support Third Party Operations (TPO). In this regard, we are looking for an experienced and responsible professional for the position MANAGER LAUNCHES AND SWITCHES to join the TPO division. MISSION OF THE ROLE: The Manager Launches and Switches will be responsible for warranty of the current pharmaceutical standards, statutory and regulatory requirements of products for Launches and Switches and ensures that all key projects regarding all quality issues are in compliance with regulations and corporate standards. RESPONSIBILITIES: • QA Due Diligence - Evaluation of a new supplier and/or manufacturer, respectively of a new product foreseen for licensing in.  - Performance on the basis of already available documents in combination with practical observation of the business with this manufacturer (e.g. SWOT). - The goal is to give proof if a certain contract manufacturer is able to follow global company’s standards.  - Evaluation of the current cGMP (Corporate Good Manufacturing Practices) and audit status. Participation in on-site audits, if required. • Regulatory compliance - Ensure that all regulatory variations were done with the contract manufacturer; conduct RA (Regulatory Affairs) maintenance; insure that all available documents are of the current status.  - Coordination of analytical methods, transfers and stability tests (bulk and OGS). • Supplier Qualification - Ensure a proper supplier qualification that manufacturing, packaging, testing and release is done according to cGMP rules, and the relevant Marketing Authorization and all regulatory requirements are met.  - Supplier Qualification is based on a Supplier Due Diligence Procedure.  - Ensure launch projects are delivered on time and meet the target success criteria regarding all quality issues.  - Participation in NPI (National Provider Identifier) TPO Meetings, PLT (Platelet) • Product evaluation and commitment to market release / batch release: initiation and deadline monitoring of all quality relevant activities. • Manufacturing Process Validations: evaluate the manufacturing process validation to ensure the robustness of the product. • Tech Transfers /Switches - Coordinate the know-how transfer from one production site to another site and/or switches of an existing marketing authorization to another registration.  - Ensure that cGMP rules, the relevant Marketing Authorization and all regulatory requirements are met.  - Participation in Transfer Project Meetings. REQUIREMENTS AND COMPETENCES: • Degree in Pharmacy, Science, Engineering or similar • Pharmaceutical manufacturing or validation related experience • Analytical control of drugs and regulatory compliance experience • Experiences in statutory and regulatory requirements and guidelines of pharmaceutical products • Results and customer oriented professional with good analytical and communication skills  • Ability to work under pressure with tight deadlines • Very good in written and spoken English • Willingness to travel, also international  • Proficiency in MS Office, SAP and Track Wise® THE COMPANY OFFERS: • Chance to join a global pharmaceutical company • Professional working environment providing opportunities for development • Competitive remuneration package Should you see yourself in the described role, please send us your updated CV in English. Only short-listed candidates will be approached.  All applications will be considered under the terms and conditions of confidentiality in accordance with the regulations of personal data protection. Wyser EOOD activities are based on a Recruitment license №2311 issued on 13.07.2017, valid indefinitely.
Обяви за работа