vacature kwaliteit

Plant Specialist QA /QP

Derks & Derks

Responsible position within an international environment / promote a culture of continuous improvement and quality

Offer

  • prominent role within a solid and strong pharmaceutical company
  • a great opportunity to be part of a growing company
  • responsible role within the QA department
  • work on your own development with valuable opportunities to broaden your experience and maximize your potential
  • attractive benefits package

Organisation

Our client is an innovative, global pharmaceutical organisation, with presence in approximately 100 countries worldwide. Our client is science orientated and challenges itself in being a dedicated entrepreneurial in Pharma. At their location in The Netherlands, medicines are labelled, packed and distributed to various countries around the world. Within the organisation more than 600 professionals work together to maintain the high quality of their products, which will be distributed to the rest of Europe. Because of internal movements the organisation is looking for an experienced Plant Specialist QA/QP.

Position

In this role you will act as Qualified Person. You will be responsible for releasing finished drug product lots while ensuring compliance with the requirements of the marketing authorisation and good manufacturing practices. As a Plan Specialist QA/QP, you will provide guidance and direction to Production, Maintenance & Engineering and Quality staff regarding compliance with quality standards and procedures. You will partner with production staff in performing risk analysis and the establishment of quality limits and requirements. You will own, review and approve production and plant QA related documents (e.g. SOPs, Forms, Training). Also, you will review and approve deviations and CAPA, initiate and own as needed is a responsibility. You will perform impact assessment as part of change controls impacting production or QA processes. Furthermore, you will review and approve production equipment maintenance work orders and approve test protocols before use in production. You will perform GMP compliance checks in production and participate in internal audits and lead as appropriate. Participating in regulatory inspections and partner audits is included in the position as well. You will assist in development and delivery of GMP training for QA and production staff. You will lead and participate in Plant QA related projects/global QA initiatives as needed. And you will lead and assist in various investigations as needed, as well as assist in validation activities as needed including review and approval of validation documents.

Profile

  • M.Sc. in Pharmacy, Industrial Pharmacy, Bio-engineering or comparable
  • good knowledge of Quality Assurance principles, GMP and GDP
  • thorough knowledge of the processes involved in clinical and commercial manufacturing (GMP), warehousing, supply chain, equipment engineering principles and validation
  • knowledgeable and skilled to fulfill the requirements of EU directive 2001/83/EC article 49 (Qualified Person)
  • fluent in both English and Dutch

Response

Interested? Please send your resume and motivational letter by e-mail, with reference to WL/19-049-DD to Vera Hudepohl : info@derksenderks.nl. For further information, please call Vera Hudepohl at number +31 (0)33 472 80 87.

An individual assessment may be part of the selection procedure.

Our Client has chosen Derks & Derks B.V. as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.

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