Senior Executive - QA Validation

USV PRIVATE LIMITED; Gujarat; On-site; INR 850,000 - 1,100,000; Full time

Job summary

USV PRIVATE LIMITED in Gujarat, India, seeks a Qualification and Validation specialist to draft, review, and execute IQ, OQ, and PQ protocols for critical manufacturing and lab equipment.

You will collaborate with QA, Validation, Engineering and Operations to ensure cGMP, FDA/EMA/ISO compliance, handle deviations, and support calibration and maintenance programs for ongoing equipment qualification.

Qualifications

Responsibilities

• Protocol Execution: Draft, review, and execute IQ, OQ, and PQ protocols for equipment.
• Risk Assessment: Perform FMEA and data integrity assessments to identify critical process parameters.
• Vendor & Asset Coordination: Collaborate with vendors to review design specs, FAT/SAT data.
• Standards Compliance: Ensure qualification activities comply with cGMP, FDA, EMA, ISO, and 21 CFR Part 11.
• Deviation Management: Investigate and resolve deviations during qualification runs.
• Calibration & Maintenance Support: Work with maintenance to set calibration limits and SOPs.
• Re-qualification Oversight: Plan periodic re-qualifications and manage change impacts.
• Cross-Functional Collaboration: Coordinate with QA, Validation, Engineering, and Operations for handover

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.