We are looking for a responsible Executive/ Senior Executive- QA Analytical for laboratory computerized system validation, data integrity, instrument qualification, calibration, and regulatory compliance. The role includes IQ/OQ/PQ, validation documentation, audit trail review, ValGenesis VLMS, risk assessment, change control, SOPs, CAPA, QMS, and laboratory compliance in coordination with vendors, IT, and cross-functional teams.

Key Responsibilities:
- Ensure qualification and calibration of laboratory instruments, equipment, and computerized systems as per regulatory requirements.
- Prepare and review URS, Validation Plan, Risk Assessment, IQ/OQ/PQ, Traceability Matrix, and Validation Summary Report.
- Track and coordinate computerized system validation activities with vendors and cross-functional teams.
- Coordinate software implementation/upgradation with vendors and corporate teams through ValGenesis VLMS.
- Provide support for troubleshooting and optimization of laboratory analytical software applications.




- Review audit trails of chromatography and non-chromatography computerized systems as per SOPs.
- Conduct periodic risk assessments, system reviews, data backup/restoration, and compliance checks.
- Ensure data integrity and regulatory compliance across laboratory computerized systems.
- Handle change controls, including evaluation, assessment, implementation, and closure.
- Prepare and review SOPs and laboratory procedures related to computerized systems and compliance.
- Conduct periodic data/query reviews to identify potential data manipulation or tampering.
- Review laboratory SOPs and ensure adherence to applicable regulatory guidelines and procedures.
- Track and maintain QMS records, analytical incidents, CAPA, and other compliance documents.
- Review and approve calibration, preventive maintenance, and annual maintenance schedules.
- Maintain laboratory records, equipment/instrument lists, organizational records, and other controlled documents.
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📌 Executive/ Senior Executive- QA Analytical (Mumbai)
🏢 FDC
📍 Mumbai