Qualified Person Als Quality Operations Group Lead Compliance (m/w/d)

microsatsystems.biz

Unterschleißheim, Germany
Qualified person (qp) certification eu 2019/6
Gmp compliance in sterile manufacturing
Team leadership of quality operations group
This role combines hands-on operational tasks with strategic leadership to ensure global product quality for humans and animals

Job Summary

  • This role combines hands-on operational tasks with strategic leadership to ensure global product quality for humans and animals.
  • The successful candidate will lead a team of seven, manage batch releases as a Qualified Person, and represent the site in the global network.
  • The position requires high visibility on the shop floor, close collaboration with production teams, and active participation in GMP inspections.

Matching Summary

This role combines hands-on operational tasks with strategic leadership to ensure global product quality for humans and animals.

Skills & Requirements

Must-have

  • Qualified Person (QP) certification EU 2019/6
  • GMP compliance in sterile manufacturing
  • Team leadership of Quality Operations group
  • Batch release authority responsibilities
  • Deviation management and complaint handling

Nice-to-have

  • Experience with aseptic validation processes
  • Strategic quality system development skills
  • Proactive problem-solving approach
  • Global network collaboration experience

Key Requirements

  • QP qualification per Article 97 Abs. 2 and 3 EU Regulation 2019/6
  • Degree in Chemistry, Pharmacy, or Biotechnology
  • Multi-year pharmaceutical industry experience
  • Sterile drug manufacturing expertise

Work Rights

Not specified

Tailored Resume

Cover Letter