We are looking for an experienced Quality Assurance professional with 6–7 years of relevant experience in pharmaceutical validation activities. The candidate will be responsible for managing qualification and validation processes, ensuring GMP compliance, maintaining validation documentation, supporting audits and inspections, and implementing quality risk management practices as per regulatory requirements.
Key Responsibilities:
Prepare and review validation protocols, execution reports, and Validation Master Plans (VMP).
Manage qualification of plant areas and equipment, including autoclaves, vessels, filling and packing machines.
Prepare and review technology transfer documents, Site Master File (SMF), and other validation-related documentation.
Track calibration and qualification activities to ensure timely completion and regulatory compliance.
Prepare Quality Risk Management (QRM) assessments for plant areas and equipment.
Investigate validation deviations and implement appropriate Corrective and Preventive Actions (CAPA).
Support internal and external audits and regulatory inspections, including preparation of responses and closure of observations.
Ensure compliance with WHO-GMP, Schedule M, US FDA 21 CFR 210/211, EU GMP, and applicable PIC/S requirements.
Manage validation documentation, including URS, DQ, IQ, OQ, PQ, PPQ, and continued process verification records.
Support Computerized System Validation (CSV), utilities validation, and data integrity compliance.
Apply risk assessment methodologies, including FMEA and ICH Q9, to identify and mitigate quality risks.
Maintain accurate validation records and ensure compliance with approved SOPs, documentation practices, and ALCOA+ principles.
Coordinate with Production, Engineering, and other cross-functional teams to ensure effective execution of validation activities.
Train newly joined employees on validation procedures, documentation, and applicable quality standards.
Key Requirements:
B. Pharm / M. Pharm qualification is mandatory.
6–7 years of relevant experience in pharmaceutical validation activities.
Strong hands-on experience in equipment and area qualification, preferably involving IQ/OQ/PQ.
Good knowledge of process validation, PPQ, CPV, CPPs, CQAs, and statistical evaluation.
Experience in validation of utilities, including water systems, HVAC, and compressed air systems.
Knowledge of Computerized System Validation (CSV), 21 CFR Part 11, EU Annex 11, and data integrity requirements.
Strong understanding of WHO-GMP, Schedule M, US FDA, EU GMP, and applicable regulatory guidelines.
Proficiency in validation documentation, including VMP, protocols, reports, deviations, change controls, and CAPA.
Knowledge of Quality Risk Management, ICH Q9, FMEA, and risk-based validation approaches.
Good communication, documentation, analytical, and problem-solving skills.
Ability to manage multiple priorities, work collaboratively across departments, and maintain high standards of accuracy and compliance.
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