QA Specialist Pharmacovigilance
For our client, a pharmaceutical company based in the French part of Switzerland, we are looking for a permanent position a :
Quality Assurance Specialist
- Being the point of contact for the authorities, customers, and suppliers
- Identify, assess and manage risks, provide reports on key risks and issues
- Investigate and provide quality reports, audit suppliers
- Develop a robust pharmacovigilance quality system and be the responsible person for the entire QMS in the relevant areas/aspects i.e. pharmacovigilance.
- Act as the sole responsible for pharmacovigilance compliance with the Swiss and EU laws, rules and regulations and local SOPs, also for external contractual partners, including training of the safety team and SOP maintenance.
- Ensuring submission of all pharmacovigilance-related documents to the competent authorities.
- Monitor and assess safety processes and procedures
- Monitor deviations, escalate as necessary and maintain CAPA oversight for all audits and Inspections
- Lead the preparation, host and follow up on Regulatory Authorities inspections related to Pharmacovigilance
- Bachelor or Master degree preferred in health/life sciences, pharmaceutical sciences or health related field
- Experience in Pharmacovigilance (as QPPV)
- Experience in the development of a PV Quality Management System
- Quality inspection, auditing and testing experience as well as experience with CAPA -Corrective Action/Preventive Action and experience in Change Controls
- Knowledge of tools, concepts and methodologies of QA
Please apply online. Aymeric Shimamungu is your Kelly contact