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Quality Assurance Manager / Junior Qualified Person
The company
For a strong international organization in the pharmaceutical industry, we are currently looking for an ambitious Junior Qualified Person. The company is a manufacturing organization and operates in more than 40 countries across the globe! A great environment to develop yourself in!
Role description
In this role you’ll be responsible for the release of batches of several CMO’s, 3 in Europe and 1 in Canada. It is a very dynamic role which requires effort and hard-work to grow into the Qualified Person role. It’s necessary to have 5+ years of experience within Pharma Quality Assurance & a MSc. In either (Industrial) Pharmacy or (Bio-)Chemistry.
Responsibilities
Review of batch documentation of branded, and APIs 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 training for employees
Requirements
5+ Years of experience as Quality Assurance Specialist within the Pharmaceutical Industry
5 + years of experience in GMP and GDP
MSc. In either (Industrial) Pharmacy or (Bio-)Chemistry
Fluent in English
Ambitious, dedicated & hard-working
For more information please contact Nawin Ramsaran at n.ramsaran@sire-search.com or +31 (0) 20 658 9800.
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