AGM:- Quality Assurance

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) program by integrating risk-based decision making across product lifecycle activities, ensuring risks are identified, assessed, mitigated, communicated, and periodically reviewed in accordance with ICH Q9(R1).Ensure data integrity and documentation compliance by implementing controls aligned with ALCOA++ principles, Good Documentation Practices (GDP), electronic record requirements, audit trail review, controlled access, data governance, and periodic data integrity assessments.Lead inspection readiness and regulatory compliance activities, including preparation, management, and response to inspections and audits conducted by regulatory authorities, customers, and corporate quality organizations, ensuring timely closure of observations and regulatory commitments.Develop, qualify, monitor, and periodically evaluate suppliers, contract manufacturers, contract laboratories, and service providers through risk-based qualification, quality agreements, performance monitoring, audits, and ongoing compliance oversight.Review and approve quality-impacting changes by ensuring comprehensive change control, regulatory impact assessment, validation requirements, risk evaluation, and implementation of appropriate controls before execution.Monitor quality performance through quality metrics, trend analysis, Annual Product Quality Reviews (APQR/PQR), management reviews, and continuous improvement initiatives, driving operational excellence and sustained GMP compliance throughout the organization.Establish and maintain an effective quality culture by ensuring GMP training, competency development, quality awareness, ethical practices, regulatory knowledge, and cross-functional engagement while promoting continuous learning and accountability at all organizational levels.Responsible and supporting new product introduction, technology transfer, lifecycle management, contamination control strategies, digital quality systems, regulatory intelligence, and implementation of evolving global GMP expectations and industry best practices.