QA Associate

Summary

Join us in this exciting journey to make a positive impact in patient's lives as a QA Associate, supporting the QA team to ensure internal/external audits are developed, managed, maintained, and delivered in line with PrimeVigilance procedures.

Requirements

• Previous experience in the pharmaceutical and/or regulated industry in a quality setting – preferably in Pharmaceuticals or Healthcare
• Good overview of the principles of Quality Assurance
• Experience of participating in audits and inspections
• Excellent communication and facilitation skills within a global organization
• Organization skills, including attention to details and multitasking
• English advanced – spoken and written

Responsibilities

• Hosts/supports audits (routine, due diligence, qualification) and inspections of Primevigilance performed by clients/third parties and regulatory authorities as agreed with Quality Audits Manager and/or Director, Quality
• Supports PrimeVigilance functional teams pre-, during and post-audit by clients or by internal QA function
• Assists in client specific requests for audit scheduling
• Assists in maintenance of trackers involved for audit related tasks and the maintenance of the SharePoint
• Supports the oversight, maintenance, scheduling of audits and inspections of PrimeVigilance performed by clients/third parties and regulatory authorities
• Supports in tracking of the vendor audit CAPAs
• Support in the facilitation and review of vendor CAPA responses
• Input into the global audit CAPA tracker
• Ensures documents and trackers from internal system and/or vendor audits initiated by Primevigilance, are kept up to date
• Assists in the development and maintenance of the internal risk assessments