Sr. Executive - AQA

Role & responsibilities:

• Audit lab data: Verify raw analytical data, electronic chromatograms (HPLC/GC), and computerized system audit trails to enforce ALCOA+ data integrity.
• Manage lab QMS: Lead investigations for deviations, Out of Specification (OOS) results, and execute corrective action (CAPA) plans.
• Review batch release: Cross-verify final laboratory results and Certificates of Analysis (CoA) against product specifications prior to final approval.
• Oversee validation: Approve protocols for analytical method validation (AMV), instrument qualifications (IQ/OQ/PQ), and 21 CFR Part 11 compliance.
• Control documents: Author, update, and track Standard Operating Procedures (SOPs), standard testing procedures, and chemical reagent logs.
• Ensure audit readiness: Maintain continuous laboratory compliance to successfully face strict inspections from regulatory bodies like the USFDA.

Preferred candidate profile:

Preferred Candidate Profile: API Pharmaceutical Background