- Lead and maintain the Pharmaceutical Quality System (PQS) by establishing, implementing, monitoring, and continuously improving quality systems in compliance with ICH Q7, ICH Q9(R1), ICH Q10, applicable cGMP regulations, and company quality policies to ensure a state of continuous regulatory compliance.
- Should be very much conversant with the implementation and monitoring of computerized systems validation (CSV), Caliber LIMS/QMS/DMS.
- Provide independent Quality Unit oversight to the plant for all GMP operations, including manufacturing, warehousing, laboratories, engineering, validation, utilities, computerized systems, contract service providers, and supply chain activities, ensuring quality decisions remain independent of operational and commercial influences.
- Authorize/do the release or rejection of APIs, intermediates, raw materials, packaging materials (where applicable), and quality records after ensuring compliance with approved specifications, validated processes, regulatory requirements, and GMP documentation.




- Ensure effective implementation and governance of Quality Management Systems , including document control, deviations, investigations, CAPA, change control, risk management, complaints, recalls, annual product quality reviews, training, supplier qualification, and management review.
- Ensure robust investigation and resolution of quality events , including deviations, Out-of-Specification (OOS), Out-of-Trend (OOT), laboratory incidents, customer complaints, and critical quality issues through scientifically sound root cause analysis and effective CAPA implementation.
- Provide Quality Assurance oversight and approval of qualification and validation activities , including facilities, utilities, equipment, processes, cleaning, analytical methods, computerized systems, transport, and continued process verification to ensure ongoing validated state and regulatory compliance.
- Establish and sustain an effective Quality Risk Management (QRM) pro

📌 AGM:- Quality Assurance (Gujarat)
🏢 Cadila Pharmaceuticals
📍 Gujarat