Вторник, 25 Юли 2017 г.
новини от последните 24 часа: 934
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MANAGER COMPLIANCE in WYSER
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 №1482 issued on 30.07.2012, valid until 30.07.2017
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