SIRE Life Sciences®

Junior Qualified Person

Location: NOORD-HOLLAND, Netherlands

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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SIRE Life Sciences®

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