Senior Executive - QA Validation
Job Description
Protocol Execution: Draft, review, and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for critical manufacturing and lab equipment.
Risk Assessment: Perform failure mode and effects analysis (FMEA) and data integrity assessments to identify critical process parameters and equipment risks.
Vendor & Asset Coordination: Collaborate with equipment vendors to review design specifications (FAT/SAT), technical manuals, and factory acceptance testing data.
Standards Compliance: Ensure all qualification activities strictly comply with cGMP, FDA, EMA, ISO, and 21 CFR Part 11 guidelines.
Deviation Management: Investigate, document, and resolve technical deviations, non-conformances, or protocol failures during qualification runs.
Calibration & Maintenance Support: Partner with maintenance teams to establish preventative maintenance schedules, calibration limits, and standard operating procedures (SOPs).
Re-qualification Oversight: Plan and execute periodic equipment re-qualifications and manage change control impacts on existing validated equipment.
Cross-Functional Collaboration: Coordinate with Quality Assurance (QA), Validation, Engineering, and Operations teams to ensure smooth equipment handover to production.