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Compliance and Quality Manager
Vor 7 Tagen
An Exciting Opportunity Awaits
Career opportunities abound with CTC Resourcing Solutions. We connect talented individuals with innovative companies that value excellence and growth.
We seek a seasoned Quality Assurance Manager for a long-term position in Basel, Switzerland. Join our esteemed client, a leading pharmaceutical company dedicated to advancing healthcare.
Main Responsibilities:
- Provide quality assurance oversight for GCP/PV/GLP activities within the organisation and at vendor/investigator sites for assigned studies/compounds.
- Support and coordinate vendor qualification activities, including audits.
- Collaborate with the team to enhance the Quality Management System (QMS) and related processes, including document updates.
- Evaluate and address non-conformances related to relevant GCP/PV/GLP deviations, quality issues, investigations, CAPAs, and change control.
- Monitor and report audit results.
- Plan and execute internal or external training sessions.
- Participate in departmental and cross-functional compliance initiatives as assigned.
- Serve as the QA point of contact for vendors/investigator sites related to GCP/PV/GLP studies.
- Support a risk-based approach to QA activities (GCP/PV/GLP).
- Assist in preparing for and conducting audits and inspections at client sites and partners as required.
- Communicate critical issues to the Head of Global Quality Management and propose mitigation strategies.
Requirements and Qualifications:
- A valid working/residency permit or Swiss/EU citizenship is mandatory.
- Minimum 5 years' experience in the pharmaceutical industry, with 3 years in QA GCP/GVP.
- Bachelor's or Master's degree in pharmacy, chemistry, or a related field.
- Familiarity with GCP and PV regulations.
- Product development process knowledge and cross-functional teamwork experience.
- Auditing experience in GCP, PV, and GLP; auditor certification is desirable.
- GCP/GVP-related Health Authority Inspection experience.
- Effective communication and presentation skills, with fluency in English.
