I'm recruiting for a Qualified Person (QP) to join a dynamic and rapidly growing organization in the Randstad area. As an integral member of our Regulatory Affairs (RA) team, you will play a pivotal role in ensuring compliance with Good Manufacturing Practice (GMP) regulations for medicines and medical devices with a specific focus area of clinical trials.
- Collaborate with cross-functional teams, including Product Management, to develop and execute regulatory strategies for new products.
- Authorize quality documents and ensure adherence to regulatory requirements.
- Stay updated on regulatory changes and provide recommendations for necessary actions.
- Conduct audits at supplier sites to ensure compliance with GMP standards.
- Address complaints and identify areas for improvement to enhance quality and regulatory practices.
- Participate in the recall committee and contribute to the execution of product recalls as per established procedures.
- Review contracts to ensure mutual compliance with GMP responsibilities.
- Provide guidance and act as an information resource on GMP matters and relevant legislation for company employees.
- Master's degree in Pharmacy or equivalent, along with a pharmacist's certificate.
- Successfully obtained the Qualified Person certificate/training.
- Experience with clinical trials
- Demonstrated experience in a GMP environment or the pharmaceutical industry.
- Strong decision-making skills and the ability to prioritize quality-conscious decisions.
- Excellent command of the Dutch and English languages, both written and spoken.
- Location: Lelystad, The Netherlands
- Contract Type: Perm position
- Start date: ASAP
- Hybrid-working is a possibility
Interested or know someone?
Reach out to Khanyi Mabena for more information by contacting +31 (0)20 20 44 502 or firstname.lastname@example.org