Munich Quality Assurance Specialist

vor 1 Monat


Munich, Bayern, Deutschland Triga Consulting GmbH & Co KG Vollzeit
About the Role

We are seeking a seasoned Qualification Engineer to join our client, a leading biotechnology company based in Munich.

The ideal candidate will possess extensive experience in equipment qualification and GMP-compliant documentation, with a strong understanding of current GMP guidelines.

This is an excellent opportunity to work on high-profile projects, contribute to the development of new products, and collaborate with a talented team.

Key Responsibilities
  • Plan and execute qualification of equipment, devices, systems, facilities, and associated software.
  • Conduct market research and obtain quotes based on requirement specifications.
  • Prioritize and manage multiple tasks, ensuring timely completion of projects.
  • Analyze risks, develop measures, and implement solutions.
  • Prepare SOPs and work instructions.
  • Leverage expertise to train employees on equipment operation and compliance procedures.
Requirements
  • Bachelor's degree in a scientific field or relevant experience.
  • At least 5 years of experience in the pharmaceutical industry.
  • Proven track record of success in equipment qualification and GMP documentation.
  • Familiarity with EU GMP Annex 11, 21 CFR Part 11, and GAMP 5.
  • Excellent communication and teamwork skills.
  • Language proficiency: German C1 - English B2.
What We Offer
  • A competitive salary range of €80,000 - €110,000 per year, depending on experience.
  • A diverse work environment with opportunities for growth and development.
  • Flexible working hours and a generous vacation policy.
  • A comprehensive benefits package, including health insurance and retirement savings plan.


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