QA Manager (m/f/d)

  • Support quality related activities in the development center to ensure compliance with systems and policies
  • Contribute to the development and life cycle management of drugs and formulations according to § 3 Abs. 2 BApO
  • Oversee the product development from a quality perspective and advice the development teams on GMP relevant questions
  • Actively provide information on GMP requirements for the manufacture and release of clinical trial supplies to the project teams
  • Ensures compliance that each batch of investigational medicinal product has been manufactured and tested in accordance with the legal and registration requirements (e.g. AMG, AMWHV, EG-GMP-Guideline)
  • Supports the creation of audit plans for internal and external audits
  • Immediately escalates quality and compliance issues to SDC Quality Management
  • Academic degree in Science (pharmacy, chemistry, biology or similar)
  • Minimum 3 years professional experience in quality control (QC) or quality assurance (QA) or quality management (QM) in pharmaceutical industry
  • Good knowledge in GMP and regulatory guidelines in pharmaceutical industry
  • Fluent in English essential for business, good command in German of advantage

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83607 Holzkirchen