Senior Compliance Specialist (Part-Time) | Senior Compliance Specialist Teilzeit (m/w/d)
FERCHAU GmbH Niederlassung Ulm
Job Summary
This part-time Senior Compliance Specialist role within the Pharma and Life Science sector involves ensuring the cGMP-compliant operation of pharmaceutical production facilities, including cleanroom and clothing design. The specialist will be responsible for interpreting and implementing regulatory requirements, such as EU-GMP and FDA standards, to optimize operational processes. Key tasks include preparing for and supporting audits and inspections, managing resulting observations, and implementing Corrective and Preventive Actions (CAPAs). The role also involves consulting on facility projects throughout their lifecycle (implementation, modification, expansion) and acting as the primary contact for GMP-compliant documentation related to changes, deviations, and events. Candidates must possess a scientific background, professional experience in the pharmaceutical industry, and strong knowledge of biopharmaceutical manufacturing regulations, combined with excellent presentation and organizational skills.
Required Skills
Education
Completed scientific university degree (Master/Diploma) or Master Craftsman certification with relevant professional experience (e.g., Chemistry, Biochemistry, Biology, Pharmacy, or Food Technology)
Experience
- Professional experience in the pharmaceutical industry (e.g., Quality Assurance, Production, Quality Control, or Microbiology)
- Experience in interpreting and implementing regulatory requirements (EU-GMP, FDA)
- Experience in preparing for and supporting audits and inspections
- Experience with quality events, deviations, and change management
Languages
Additional
- Part-time position (10 hours per week mentioned for salary calculation); Must possess assertiveness for successful handling of quality events.
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