QA Auditor for CMO and Pharma Supply
Vor 4 Tagen
Responsibilities:
- Provide QA oversight for GCP / PV / GLP activities within the company and at vendor / investigator sites for assigned studies / compounds
- Support and coordinate vendor qualification activities, including audits
- Support continuous improvement of the Quality Management System (QMS) and related processes, including establishing and updating QMS documents
- Ensure timely and appropriate management of non-conformances related to relevant GCP / PV / GLP deviations, quality issues, investigations, CAPAs, and change control
- Ensure audit results are formally tracked, recorded, and reported
- Coordinate and lead internal or external training activities
- Support departmental and cross-functional compliance initiatives as assigned
- Act as QA contact person for vendors / investigator sites for related GCP / PV / GLP studies
- Support and contribute to a risk-based strategy for QA activities (GCP / PV / GLP)
- Support inspection readiness and vendors conducting GCP, PV, and GLP activities through review of audit findings, CAPA generation and review, and training
- Support preparation, conduct, and follow-up of audits and inspections at client sites and partners as required
- Report critical issues to the Head of Global Quality Management, assess their impact, and propose risk mitigation as appropriate
- Establish and manage work orders with external QA consultants and CROs
- Maintain a high level of knowledge of current GxP regulations
Qualifications and Experience:
- Relevant working / residency permit or Swiss / EU-Citizenship required
- Minimum 5 years of experience in the pharmaceutical industry and a minimum of 3 years' experience in QA GCP / GVP
- University or master's degree in pharmacy, chemistry, or equivalent
- Working knowledge of GCP and PV legislation
- Knowledge of product development processes and experience in cross-functional teamwork
- Experience in auditing GCP, PV, and GLP; an auditor qualification would be an asset
- Experience in GCP / GVP related Health Authority Inspections (FDA, BfArM, other HA)
- Ability to work both independently and collaboratively, well-organized and structured
- Excellent communication and presentation skills at different levels
- Fluency in English, written and spoken, is essential; any other language would be beneficial
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