3D-PharmXchange is a Dutch Life Sciences consultancy and operational support firm located in Tilburg and Oss. We are dedicated to the development of (bio-) pharmaceuticals and diagnostics. Our team of experts covers the key areas of pre-clinical, clinical, 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.
QA Specialist/Consultant – GMP/GDP
3D-PharmXchange is looking for a QA specialist/consultant – GMP/GDP, with experience in 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 it’s 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 the Quality Management System (QMS)
- Development/maintenance of GMP related procedures
- Training of colleagues
- 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 prequisite
- Excellent knowledge of spoken and written English
- Autonomous as well as a team player
- Decisive and proactive
- Accurate and quality aware
Acquisition is not appreciated!
Please attach your CV to our contact form!