Quality Assurance Specialist - Quality System | Quality Assurance Specialist - Quality System (x|w|m) - On-site
Sartorius Corporate Administration GmbH
Job Summary
This role involves preparing a new production site for operation by ensuring all quality assurance measures comply with GMP and ISO 9001 regulations, internal standards, and corporate guidelines. The specialist will maintain and develop the quality management system, including deviation, CAPA, change control, and complaint management. Key responsibilities include managing employee training and qualification, conducting QM system training, and planning/executing internal and external audits. The position also requires managing electronic document and quality management systems, integrating new regulatory requirements, and participating in risk analyses. This is an on-site, full-time, permanent position in Freiburg, offering the chance to contribute to a growing life science company.
Required Skills
Education
Completed degree in Pharmacy, Natural Sciences, or comparable qualification
Experience
- Several years of professional experience in quality assurance within a GMP/ISO 9001 environment
- Professional experience in the pharmaceutical industry (preferred)
- Qualification as an Auditor (advantageous)
- Experience in planning and conducting audits (advantageous)
- Initial experience with electronic document management and quality management systems (ideal)
Languages
Additional
- On-site work at the Freiburg location
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