Copy of Quality Assurance Officer

The Quality Officer will support all audit activities within PrimeVigilance and will work with the Auditing team and Quality teams to ensure audits are delivered in line with PrimeVigilance and procedures and global regulation.

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