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.

- Ensure training and SOP compliance of laboratory personnel.

- Conduct daily laboratory compliance rounds and self-inspections and report observations to the Department Head.

- Participate in implementation of new procedures, systems, and compliance initiatives for effective laboratory operations.

Additional Responsibilities:

- Review laboratory SOPs and general procedures for compliance with applicable regulatory guidelines.

- Ensure all laboratory data is generated and documented in accordance with approved SOPs and regulatory requirements.

- Track and update QMS documents, including Analytical Incidents, CAPA, and related records.

- Handle laboratory change controls, including evaluation, assessment, implementation, and closure.

- Review and approve calibration schedules for laboratory instruments and equipment.

- Review and approve Annual Maintenance and Preventive Maintenance schedules for laboratory equipment.

- Prepare and continuously update organizational charts, employee lists, and instrument/equipment lists.

- Issue and maintain laboratory records, including laboratory notebooks, analytical work records, logbooks, current column records, and methods of analysis.

- Ensure laboratory personnel are appropriately trained on SOPs and laboratory procedures.

- Monitor compliance with SOPs during routine laboratory operations.

- Conduct daily laboratory rounds to identify and address compliance gaps.

- Conduct self-inspections and prepare inspection reports for the Department Head.

- Perform any other responsibilities assigned by the reporting manager/Department Head.

📌 Executive/ Senior Executive- QA Analytical (Mumbai)
🏢 FDC
📍 Mumbai