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Quality Assurance Manager GCP/PV/GLP
Our client is an innovative mid-size pharmaceutical company with global headquarters in the German-speaking part of Switzerland. A well-funded and stable organisation, our client enjoys the backing of a number of leading, globally recognised institutions. They are currently market leaders in anti-infectives via a global alliances and extensive partner network. We have a long-standing relationship with this company and have placed a number of key people in the organisation in the past, all of whom have given us some great feedback from their time working there.
We are currently looking for a Quality Assurance Manager for a permanent contract based in Basel area, Switzerland .
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
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
Would you like to learn more about CTC and the opportunity outlined? Please, get in contact with us: you may either use the 'apply now' button, or write an email to us, or reach out to us on the phone.
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