Munich Quality Assurance Specialist
vor 1 Monat
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.
- 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.
- 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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