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GCP and PV Compliance Expert
vor 1 Woche
Clients in the pharmaceutical industry rely on us to provide them with top talent. We are now seeking a GCP and PV Compliance Expert to help us meet this demand. This individual will be responsible for ensuring that all aspects of our clients' operations comply with GCP and PV regulations.
Main 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 establish and update 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 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
Key Qualifications:
- 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
