Executive/ Senior Executive- QA Analytical

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, new 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.