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QP IMP

Job description

QP IMP – The Randstad, Netherlands

BioTalent is currently supporting a leading global pharmaceutical organisation that is seeking a highly motivated and experienced QP for Investigational Medicinal Products (IMP). As the IMP QP, you will have the opportunity to work globally with a variety of new products across a range of therapeutic areas.

Key Responsibilities:
  • IMP Certification: Certifies IMPs for clinical trials, ensuring compliance with EU and international GMP standards.
  • Quality Oversight: Oversees manufacturing and testing, manages deviations and audits, and supports the Quality Management System.
  • Regulatory & Documentation: Reviews GMP documentation and provides guidance on evolving regulatory requirements.
  • Training & Collaboration: Trains staff and collaborates across teams to uphold quality and compliance.

Requirements:
  • ~5 years of experience working within QA Pharma with a strong background as a QP
  • Sterile experience
  • Bachelor's or Masters degree in Pharmacy, Biotechnology, Chemistry or related
  • QP Certification recognised under EU Directive
  • 2001/20/EC with IMP certification experience pharmaceutical industry, with a strong focus on IMPs.
  • In-depth knowledge of EU GMP, GCP, and applicable regulatory requirements for clinical trials.

This is an excellent opportunity to get involved in a global leader whilst working at the forefront of science with a strong culture of collaboration.