GMP Qualification Specialist - Manufacturing | GMP-Qualifizierer (m/w/d) Herstellung
FERCHAU GmbH Niederlassung Saarbrücken
Job Summary
This role involves working within interdisciplinary teams to manage the qualification and requalification of laboratory and cleanroom facilities. Day-to-day, you will plan and implement GMP-compliant qualifications, handle change-control processes, and validate computer systems according to GAMP guidelines. You will be responsible for ensuring that technical infrastructures, such as compressed air and CO2 supplies, meet current regulatory standards while maintaining meticulous documentation using tools like TrackWise. The position requires a strong technical understanding of process plants and the ability to conduct risk assessments and deviation management. This is an attractive opportunity for a professional looking for a permanent contract with a leading engineering service provider, offering extensive benefits including a company pension, professional development through an in-house academy, and various corporate discounts.
Required Skills
Education
Degree in Natural Sciences, Biotechnology, Process Engineering, or a comparable qualification.
Experience
- Several years of professional experience in qualification under GMP conditions, specifically within the pharmaceutical or automotive industries
- Proven experience in validating IT systems and equipment in regulated environments
- Professional experience in technical documentation and the use of electronic systems like TrackWise
- Experience in managing change-qualifications and conducting risk assessments
Languages
Additional
- Permanent employment contract; requires structured and team-oriented working methods.
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