Full-Time Quality Assurance Officer

Role and ResponsibilitiesThe Quality Officer will support all audit activities within PrimeVigilance and will work with the Auditing team and Quality team s to ensure audits are delivered in line with PrimeVigilance procedures and global regulations.

The Quality Officer will perform all activities described, including but not limited to:

1. Audit Support: Supports PrimeVigilance functional teams during the pre-audit, audit, and post-audit stages for audits by clients or by PrimeVigilance internal QA function
2. Hosts onsite and remote audits
3. Provides support for regulatory inspections of clients
4. Assists in scheduling client requests for audits/inspection support

5. Administrative support
6. Supports Quality in the tracking of audit status and deliverables

7. Metrics and Key Performance Indicators
8. Supports Quality in the compilation and reporting of metrics and KPIs
9. Collects and collates data from systems and sources
10. Authors reports and summaries

11. CAPA Support Activities
12. Supports Quality in the tracking of Deviations and CAPAs
13. Facilitates CAPA response and resolution
14. Inputs data into the global audit CAPA tracker

15. Other Supportive Responsibilities
16. Supports Controlled Document preparation by reviewing draft documents, e.g., SOPs, OGs
17. Supports the PrimeVigilance Senior Leadership team as needed
18. Supports other Quality activities as needed

Requirements

• University degree in Biomedical sciences, Natural sciences or Health Sciences is required: Nursing, Pharmacy or BS/Master’s degree in a scientific discipline, or equivalent advanced degree with pharmaceutical industry experience. Or equivalent pharmaceutical industry experience.
• Previous experience in the pharmaceutical and/or regulated industry in a quality setting – preferably in Pharmaceuticals or Healthcare
• Thorough understanding of the principles of Quality Assurance
• Knowledge of national regulations and guidance related to Pharmacovigilance and Medical Information
• Experience of participating in audits and inspections
• Excellent communication and facilitation skills within a global organisation
• Proactive and self-motivated

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