Quality Assurance Officer

Role and Responsibilities

• The 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 and procedures and global regulations.

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

• 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
  • Hosts onsite and remote audits
  • Provides support for regulatory inspections of clients
  • Assists in scheduling client requests for audits/inspection support
• Administrative support
  • Supports Quality in the tracking of audit status and deliverables
• Metrics and Key Performance Indicators
  • Supports Quality in the compilation and reporting of metrics and KPIs
• Collects and collates data from systems and sources
• Authors reports and summaries
• CAPA Support Activities
  • Supports Quality in the tracking of Deviations and CAPAs
• Facilitates CAPA response and resolution
• Inputs data into the global audit CAPA tracker
• Other Supportive Responsibilities: 
  • Supports Controlled Document preparation by reviewing draft documents, e.g., SOPs, OGs
  • Supports the PrimeVigilance Senior Leadership team as needed.
  • Supports other Quality activities as needed.