MSD

Qualified Person als Quality Operations Group Lead Documentation (m/w/d)

MSD(1 month ago)

Unterschleißheim, Bavaria, GermanyOnsiteFull TimeManager$108,722 - $144,350 (estimated)Quality Assurance
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About this role

The Qualified Person (Quality Operations Group Lead Documentation) will lead a small documentation team at the Unterschleißheim manufacturing site to ensure products and materials meet stringent quality and regulatory standards. The role represents the site in the global production network and is responsible for batch certifications, maintaining quality systems and SOPs, and supporting inspections and audits. It is a fixed-term, full-time position focused on ensuring compliant, timely release and documentation of pharmaceutical products.

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Required Skills

  • GMP Regulations
  • Aseptic Handling
  • Sterile Manufacturing
  • Batch Review
  • Documentation
  • Change Control
  • Deviation Management
  • Root Cause Analysis
  • Leadership
  • Quality Systems

+2 more

Qualifications

  • Degree in Pharmacy, Chemistry, Food Technology or Biotechnology
  • Qualified Person (EU Regulation 2019/6 Article 97)
MSD

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