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Senior Manager QAE (Artwork)

2019-02-01 CLS Services | Leiden | WO / MBA | Fulltime | Sluit 2019-04-02

Are you a well-organized QA professional with experience in European GxP requirements? Are you able to play a key role in an international organization and looking for a new opportunity? Then CLS-services has an interesting job opportunity for you! As a Senior Manager QAE you are responsible ...

CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences. For our client, Astellas Pharma Europe B.V., we are searching for a Senior Manager QAE (Artwork).

Company profile
Astellas is a Japanese multinational pharmaceutical company employing over 17,000 people worldwide. The group’s EMEA headquarters are based in London, with affiliates throughout Europe engaged in research & development (R&D), manufacturing and sales & marketing. With over 4,500 employees, EMEA is an important and growing Astellas region, having key strengths in the therapy areas of Urology, Transplantation, and Oncology. In the Netherlands Astellas is located in Leiden and Meppel.



Job description
Are you a well-organized QA professional with experience in European GxP requirements? Are you able to play a key role in an international organization and looking for a new opportunity? Then CLS-services has an interesting job opportunity for you!

As a Senior Manager QAE you are responsible for realizing high quality consistency of products and processes within Supply Chain and Contract Manufacturing and contribute to QA support for the related activities and monitor them.
Next to that, your main responsibilities are:

  • Develop and maintain the Quality system for Artwork Management, Master Data Management and Supply Chain Change management for the EU region and support the related management review processes;
  • Develop and maintain the Supply Chain Change Control processes and coordinate and cooperate QA activities with Supply Chain & Contract Manufacturing and Affiliates communicating with QA and other regions;
  • Collect new developments in external Quality Assurance requirements, EMEA, ICH etc. and give the training to relevant departments;
  • Assist in preparation of the Global Audit Plan and monitoring of the plan in the EU region in relation to Artwork and Master Data management Monitoring. Reviewing of progress and findings;
  • Assessment of the consistency of the Quality System across the Affiliates, Supply Chain & Contract Manufacturing and Plants;
  • Ensuring related IT systems are in compliance with Regulatory and Corporate GxP requirements;
  • Review of implementation and maintenance of the Quality Systems of Supply Chain & Contract Manufacturing. Operate cross functional aspects of change control process and integration in Quality System.


Who we're looking for
The ideal candidate has preferably a pharmacy degree or relevant external pharmaceutical training and experience in leading (small) QA teams. You have understandings of European GxP requirements and robust knowledge of different product types. Next to that, comprehensive GMP experience within a manufacturing facility and / or regional QA role and proven GxP audit experience are key competences for this position. Finally, you have good knowledge of IT systems compliance to GxP.
As a person, you are a strong communicator, both written and spoken in English and you are good in organizing, coordinating, negotiating and presenting. In addition, you have sound decision making skills.
Are you the Senior Manager we are looking for?

Additional vacancy information
Reference: A1900012
Contract: Temporary contract with CLS Services
Education: WO/MSc.
HBO/BSc.
PhD.
Terms: Project for 6 months
Contactperson: René Kemps
Phone: +31 (0)88 22 77 555



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