Senior Compliance Specialist Part-Time | Senior Compliance Specialist Teilzeit (m/w/d)
FERCHAU GmbH Niederlassung Ulm
Job Summary
This role is for an ambitious Senior Compliance Specialist to join a leading engineering and technology service provider, focusing on the pharmaceutical and life science sectors. The specialist will be responsible for ensuring the cGMP-compliant operation of pharmaceutical production facilities, including cleanroom design, and interpreting and implementing regulatory requirements (EU-GMP, FDA) to optimize operational processes. Key day-to-day tasks involve preparing for and supporting audits and inspections, managing observations and implementing CAPAs, and providing expert consultation on facility projects throughout their lifecycle (implementation, conversion, expansion). The ideal candidate possesses a relevant natural science degree or equivalent professional qualification, extensive experience in the pharmaceutical industry, and profound knowledge of biopharmaceutical manufacturing regulations. This part-time position offers flexible working hours and the opportunity to significantly contribute to the efficiency and compliance of the quality system.
Required Skills
Education
Master's/Diploma in Natural Sciences (e.g., Chemistry, Biochemistry, Biology, Pharmacy, or Food Technology) or Master Craftsman qualification with relevant professional experience
Experience
- Professional experience in the pharmaceutical industry (Quality Assurance, Production, Quality Control, or Microbiology)
- Experience in the manufacturing of biopharmaceutical active ingredients and medicinal products
- Experience with facility projects lifecycle (Implementation, Conversion, Expansion)
Languages
Additional
- Part-time employment (10 hours per week specified for salary calculation); Must be able to demonstrate assertiveness in managing quality incidents.
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