Posted: 17 February 2022

QA Specialist/Consultant – 3D-PharmXchange

Location: Tilburg, The Netherlands
Hours: 40

 Company Profile

3D-PharmXchange is a Dutch Life Sciences consultancy and operational support firm located in Tilburg and a side office in Oss. We are dedicated to the development of pharmaceuticals and diagnostics. Our team of experts covers the key areas of pre-clinical, clinical, chemistry, manufacturing and control (CMC), regulatory affairs and project management. In addition, we provide out-licensing and interim management support. Our clients are leading big pharma companies as well as innovative biotech start-ups.

Job description

3D-PharmXchange is looking for a QA specialist/consultant – GMP/GDP, with experience in the development and (preferably) commercialization processes of a myriad of products.

Our consultants work on projects for external clients and could include both small molecules as well as biomolecules (e.g. vaccines, cell-based therapies, monoclonals). As 3D-PharmXchange supports a wide range of projects throughout all phases of drug development, you will have the opportunity to grow substantially on your know-how.

As a QA specialist/consultant – GMP/GDP (Good Distribution Practice) you will be responsible for the GMP/GDP related activities at 3D-PharmXchange and its client projects within the product development phase. For client projects, you will be responsible for:

  • Execution of external vendor audits and internal audits at our clients
  • Preparation and review of Quality agreements
  • Set-up and maintenance of Quality Management System (QMS)
  • Participating in project teams, providing guidance regarding compliant development of a product
  • Review and approval of GMP related documents that are generated during product development and clinical supplies, e.g. batch manufacturing records and validation documentation
  • Review of batch release documentation
  • Review of analytical data, methods and validations, risk assessments
  • Perform QA review on regulatory documentation (IMPD’s, IND’s, NDA’s, etc.)
  • Follow up on deviations, CAPAs and changes
  • Be involved in due diligence projects

In addition, you will take the lead in 3D-PharmXchange related activities, including but not limited to:

  • Execution of internal audits
  • Maintenance of the Quality Management System (QMS)
  • Development/maintenance of GMP related procedures
  • Training of colleagues

Requirements

  • At least an academic level or bachelor’s degree in the area of life sciences or applied science
  • Preferably at least >10 years of QA experience in a product development environment (pharma/biotech), covering all GMP aspects of QA
  • Excellent knowledge of international guidelines on quality aspects of drug development
  • Experience on commercial processes of a product is a pre
  • Excellent knowledge of spoken and written English
  • Autonomous as well as a team player
  • Decisive and proactive
  • Accurate and quality-aware

For more information about this vacancy, contact Managing Partner Albert Peters +31 6  28209882

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