Executive/ Senior Executive- QA Analytical

FDC Limited; Mumbai; On-site; INR 800,000 - 1,200,000; Full time

Job summary

FDC Limited in Mumbai is seeking an Executive/Senior Executive- QA Analytical to lead laboratory computerized system validation, data integrity, instrument qualification, calibration, and regulatory compliance. This role coordinates IQ/OQ/PQ, validation documentation, audit trail reviews, risk assessments, change control, SOPs, CAPA, and QMS with vendors and IT teams.

Responsibilities include qualification and calibration of laboratory instruments and systems, preparation of validation

Qualifications

• Experience in laboratory computerized system validation and data integrity.
• Proficient in preparing and reviewing URS, Validation Plan, Risk Assessment, IQ/OQ/PQ.
• Experience coordinating computerized system validation with vendors and cross-functional teams.
• Knowledge of SOPs, CAPA, QMS, and regulatory guidelines.

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, organisational 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.

Skills

Quality Assurance

QA Analytical

Risk Assessment

Regulatory Compliance

SOPs & CAPA

Data Integrity

Change Control

Audit Trail Review

Documentation Review

Tools

ValGenesis VLMS

Job description

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, organisational 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 organisational 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.