Qualification Manager | Qualification Manager (m/w/d)
GEA Group Aktiengesellschaft
Job Summary
This role involves leading a Quality Assurance team, focusing on the qualification and validation of pharmaceutical equipment, specifically freeze-dryers. The manager will be the primary contact for internal and external clients regarding Good Manufacturing Practices (GMP), reviewing customer specifications for feasibility from a quality assurance perspective, and ensuring compliance with various standards including material specifications, welding requirements, and performance data. Key responsibilities also include negotiating qualification and validation requirements with clients, planning and overseeing all qualification activities both in-house and on-site, and ensuring CE conformity. The ideal candidate will possess a strong background in engineering or quality management within the pharmaceutical sector, excellent negotiation skills, and a solid understanding of GMP processes. This position offers a significant opportunity to contribute to a leading provider of innovative freeze-drying solutions for the pharmaceutical industry, with a move to a new, modern production facility in Elsdorf planned for Q4 2025.
Required Skills
Education
Bachelor's or Master's degree in Engineering, Mechanical Engineering, Process Engineering, or Quality Management
Experience
- Several years of professional experience in a similar or pharmaceutical environment
- In-depth knowledge in the GMP area
Languages
Additional
- Willingness to travel nationally and internationally
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