Сряда, 26 Юли 2017 г.
новини от последните 24 часа: 945
Лупа
ASSOCIATE DIRECTOR THIRD PARTY OPERATIONS in WYSER
Wyser is an international company, part of Gi Group, one of the major international leaders in the field of services specially dedicated to labor market development. We specialize in in search and selection of middle and senior management professionals in diverse fields and sectors.

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 Associate Director Third Party Operations (Ass. Director TPO) to join the TPO division.

MISSION OF THE ROLE:
The Associate Director Third Party Operations will be responsible for managing the division and acting as Head of Quality Control Third Party Products, ensuring the manufacturing of the products is at highest quality standards and in accordance with regulatory compliance.

RESPONSIBILITIES:
• Managing batch certification according to the local regulation and EU GMP Guideline Annex 16 for national and international marked drugs with different dosage forms. 
• Ensuring that the manufacturing and testing of 3rd Party drugs, is in compliance with the regulations of GMP Guidelines and marketing authorization. 
• Taking decisions about batch certification as personal responsibility of Qualified Person in front of legal authorities. 
• Establishing that the Quality of 3rd Party products is confirmed and the stability, change control, validation, out of trend results are considered. 
• Ensuring that a proper Quality Assurance system is in place and used at the 3rd Party manufacturer and the related internal Operation areas.
• The internal Quality system for the monitoring of the 3rd Party supplier should include (among others ): Audit procedure for suppliers and subcontractors; Qualification system for suppliers and subcontractors; Quality Technical Agreements System; Ongoing stability tests; Using of validated analytical methods and productions processes; Annual Product Quality Review (PQR); Trend analysis of Deviation and OOT/OOS results; Compliance to internal company’s standards; Evaluation of weak points and market complaints, introduction of Corrective Action and follow-up; Change Control management: assurance that all changes concerning Module 3 of a dossier are submitted in collaboration with Supplier and Registration Authorities.
• Observing and following current changes and renewals, related to pharmaceutical Quality Management. Evaluating and providing proposals for implementing in his responsibility area. 
• Ensuring of performing assessments to quality issues related to Out of Specification (OOS)/Local Internet Registry (LIR) or deviation (multidrug resistance/MDR, regulatory; noncompliance, audit findings) according to company’s global guidelines: Internal information and escalation (Notifications to the Manager/NTM, General Notification to Management/GNTM, Quality Unit Assurance Manager/QUAM, Medicare Administrative Contractor/MAC; Investigation, Root Cause Analysis; Risk Assessment; Introduction of Corrective Action; Follow up of Corrective Action.
• Introducing innovative measures to optimize products robustness and processes in collaboration with 3rd Party manufacturer and other internal partners as TPO, Purchasing, Supply Chain Manager/SCM, RA.
• Providing highly qualified vendor management system in terms of Quality through collaboration with suppliers and other in-house functional stakeholders (e.g. SRMs, Procurement, Supply Chain, TSA and RA). Proactive Management and improvement of the supplier quality performance of the suppliers in the area of responsibility. Implementing, monitoring, and reinforcing Corporate Quality and TGO (Therapeutic goods orders) Standards at the Contract Manufacturing Operations/CMO sites.
• Forward-thinking planning for mid and long-term development of the department considering Vendor, Supply and Marketing strategy. 
• Ensuring synergies and opportunities for an optimized collaboration within the SRT framework and with other Quality Units, involved in Quality Oversight and Batch Certification activities within the region. 
• Collaborating with TPO on business opportunities for cost reduction, inventory management and supplier base reduction.
• Drafting of a short, mid, long term Human Resources Planning for the area of responsibility. 
• Evaluating and assessing KPIs in the department. 
• Leading, motivating and developing of employees. Talent management to support TPO
• Setting priorities and delegating responsibilities. Conducting performance reviews. 
• Defining and assessing of the annual targets. 
• Guidance and Supervision of Pharmacist trainee: Defines, approves and oversees the training program as part of the practical education of future pharmacists incl. practical education of those. 
• Participating in budget planning and execution. Approval of orders and invoices 
• For the collaboration with the Industrial Business Partner the job holder has the responsibility for: exchange of information in case of quality issues; ensuring that the Partner is well grounded about content of the Marketing authorization and advised about changes (if the MA Holder is a company belonging to client’s company). If the partner is MA Holder, it should be ensured with an appropriate change control process in place that the current status of the MA-dossier is present at client’s company. 
• Launches: coordinating all quality assurance and analytical activities for launches taking place in the Quality unit, contract labs, 3rd Party Manufacturer and/or other divisions 
• Ensuring of an optimal process-oriented organization between the sub processes and interfaces to other business units with the inclusion of all up- and downstream processes. 
• Establishing of a high level of synergy and an optimal collaboration, particularly with other quality units contributing to the quality assurance of 3rd Party Products. 
• Installation and maintenance of a network to other relevant quality representatives within the company and/or recognized authorized experts to enable a regular inter-communion about current trends and best practice in the area of pharmaceutical Quality. 
• Participation in supply targets management to avoid Out of Stocks situations.
• Ensuring of an optimal inter-communion to European Commercial Quality, particularly in case of quality issues with impact to the market. 
• Participation in monthly Quality Commercial Boards

REQUIREMENTS AND COMPETENCES:
• University degree in Pharmacy 
• 10+ years of experience in the fields of quality control/analytics, and/or quality assurance in the pharmaceutical industry
• Detailed knowledge of international pharmaceutical regulations and guidelines
• Breadth of expertise in different pharmaceutical manufacturing processes and analytical methods 
• Proven track record in negotiation with international suppliers and participation in GMP inspections
• Ability to recognize business opportunities and to implement them to major achievements and lead departments with diversified functional groups.
• Proactive Management
• Exercises considerable latitude in determining objectives and approaches to assignment.
• Acumen for interpretation of internal and external issues and for recommendation of solutions
• Acts as best practice quality resource within and outside the department.
• Experience within a matrix structure; KPIs, processes flows and reporting lines know-how.
• Fluent in business English language (written and verbal)
• Excellent MS Office and computer skills

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 №1482 issued on 30.07.2012, valid until 30.07.2017
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