Amsterdam , Netherlands
QP/ QA Manager
QP/ QA Manager
Our client manufactured and market pharmaceutical formulations and active pharmaceutical ingredients.
You are responsible for QP batch certification as per 2001/83/EC. You ensures that activities at Contract Manufacturing Organizations are conducted according to the relevant Standard Operating Procedures aligned with the Quality Assurance Agreement.
- Ensure quality oversight of manufacturing operations at the CMOs.
- Review and approval of change control notification received from third parties
- Manages all quality issues associated with the manufacturing, testing and release of Drug Products or Medical Devices originating from assigned CMO´s.
- Review and approval of annual product review (APR/PQR).
- Ensure negotiation and maintenance of Quality technical agreements with assigned CMOs.
- Ensures the sites used as third parties for manufacturing testing and storage of API and medicinal product are maintained in a qualified state by planning and executing external audits.
- Ensuring that the distribution of medicinal products complies with Good Distribution Practice
- Main point of contact for all QA related topics intern and externally.
- Participate authorities’ inspections towards the maintenance of the MIA of the site.
- Ensure local QMS is maintained up to date in accordance with Global standard policies, relevant regulations, new trend and industry standard.
- Support of Quality KPIs generation and trending as support for periodic Quality management review board.
- Ensure timely escalation to management of key quality issues while bringing proposals for resolution and impact mitigation in line with corporate standard and relevant local regulation.
- Preparation and execution of GMP/GDP training for employees.
- BSc and MSc in (Bio) Chemistry, Pharmacy, Biotechnology or similar education.
- Minimum of 5 years of relevant experience in GMP regulated environments.
- Minimum of 3 years in quality assurance departments.
- Medical Device experience and knowledge.
- Experience as Qualified Person for minimum of 2 years.
- Strong knowledge of EU GMP, US CFRs.
- Preferred additional experience in drug product sterile pharmaceutical manufacturing is an asset.
- Fluent in English.
If you are interested in this role, please contact me at email@example.com or at +31 20 658 98 00.