Junior Manager GMDP (QP/RP)
For a strong international organization in the pharmaceutical industry, we are currently looking for an ambitious Junior Qualified Person. The company is a one of the most innovatie Pharmaceutical companies in the world and have their European HQ located in Amsterdam.
In this role you’ll be responsible for the release of batches of several CMO’s in Europe. It is a very dynamic role which requires effort and hard-work to grow into the Qualified Person role. It’s necessary to have a first experience as a Qualified Person & a MSc. In either (Industrial) Pharmacy or (Bio-)Chemistry.
- Review of batch documentation and batch release in accordance with GMP and with the marketing authorizations
- Ensure quality oversight of manufacturing operations at the assigned CMOs and support from a QA technical perspective technology transfers, process validations, analytical testing and new product introductions etc.
- Review and approval of annual product review (APR/PQR)
- Ensures that the distribution of medicinal products complies with Good Distribution Practice (GDP)
- Preparation and execution of GMP/GDP audits
- 5+ Years of experience as Quality Assurance Specialist within the Pharmaceutical Industry
- 5 + years of experience in GMP and GDP
- 1+ year of experience as Qualified Person
- MSc. In either (Industrial) Pharmacy or (Bio-)Chemistry
- Solid knowledge of Small Molecules (Technical input will be required)
- Fluent in English
- Ambitious, dedicated & hard-working