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Regulatory Compliance Specialist
vor 1 Woche
CTC Resourcing Solutions AG is a dynamic bio-pharmaceutical company headquartered in Switzerland. We are seeking a highly skilled GxP and Compliance Expert to join our team. The successful candidate will be responsible for ensuring GMP/GDP compliance at third-party service providers and within internal facilities.
Main Responsibilities:
- Audit Planning and Execution: Establish external QA audit and internal self-inspection annual plans, conduct GMP/GDP audits, and coordinate with internal personnel and suppliers to schedule, execute, and follow up on audit observations.
- Critical Self-Inspection Findings: Promptly report critical self-inspection findings to the Responsible Person and Management.
- Vendor Management: Create, implement, maintain, and work with vendors on establishing quality agreements where needed.
- Quality Oversight: Provide quality oversight over equipment qualification, calibration, and validation.
Required Skills and Qualifications:
- Relevant Swiss Working/Residency Permit and/or Swiss/EU-Citizenship:
- University Degree in Pharmacy, Chemistry, or Alternative Technical/Science University Degree: Master Level Minimum:
- Minimum 3 Years' Experience in Auditing, 1 Year as Lead Auditor:
