Expert QA Operations Qualification | Biologe (m/w/d)
Daiichi Sankyo Europe GmbH
Job Summary
This role involves contributing to the qualification and validation of facilities, equipment, and computer systems at the Pfaffenhofen site. The expert will be instrumental in ensuring compliance with GMP regulations and internal quality standards, participating in all phases of qualification and validation projects (DQ, IQ, OQ, PQ). Key responsibilities include creating and reviewing validation documents, monitoring implementation, and maintaining the qualified/validated status of systems. The position requires a strong understanding of regulatory requirements and excellent collaboration skills to support various departments and prepare for regulatory inspections. It's an attractive opportunity for a detail-oriented professional passionate about quality assurance in the pharmaceutical industry.
Required Skills
Education
Degree in Natural Sciences or comparable qualification
Experience
- 3 years of practical QA experience in a GMP-regulated environment with a focus on qualification and validation (including CSV)
- Experience in pharmaceutical sterile production is advantageous
Languages
Additional
- Not specified
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