Full-Time Senior Quality Assurance Associate

Senior QA Associate is responsible for supporting the Quality Assurance (QA) team in all aspects of the design, implementation, and management of internal and external audits and corresponding Quality Risk Management activities.

Core Responsibilities:

1. Participates in scheduling, preparation, conduct, and follow-up of internal and external audits and Regulatory Authority Inspections, including management of CAPA Plans and documentation.
2. Assists QA management with meeting logistics for GQC Meetings, QA Group Meetings, and others.
3. Follows applicable processes for creating, filing, retrieving, storing, preserving, and protecting QA records.
4. Tracks and manages periodic management reports tracking quality health of GxP activities.
5. Develops and maintains Risk Assessments of vendors and internal systems/processes.
6. Develops responses to RFP/RFI and client questionnaires.
7. Supports the QA Group for assigned Process Improvement projects.
8. Undertakes other tasks assigned by QA management within individual's experience, training, and capability.
9. Trains in and complies with PrimeVigilance operating procedures.

Qualifications:

• University degree in a scientific discipline or equivalent industry experience.

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