ERGOMED is hiring a
QA Associate

Summary

Join PrimeVigilance, a specialized mid-size pharmacovigilance service provider, as a QA Associate and support the QA team in ensuring internal/external audits are developed, managed, maintained, and delivered in line with PrimeVigilance procedures.

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
• CAPA Support Activities
• 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
• The QA Associate will also support the Global Quality Function as needed
• Other QA support as needed