• To identify, define and monitor proper implementation of all documentation activities.
• Coordinate and review and approve SOPs and manage document control activities
• cGMP Coordination – Audit/audit follow up activities.
• Quality Surveillance activities.
• Identify and define the qualification and validation policies for the site, ensure the same is performed satisfactorily and authorize the qualified equipment’s and validated process.
• To lay down Training policy for the site, identify training requirements and conduct training programs.
• Batch release.
• To conduct Internal Audits and monitor implementation of corrective actions.
• Conducting Vendor Audits, Vendor Selection and monitoring.
• Handling Market Complaints and product recall.
• To handle all aspects with respect to Regulatory Affairs.
• To handle Audits by Local and International Authorities.
• Review and approve specifications, test methods and stability protocols.
• Timely approval of incoming raw and packaging materials, inspection and release according to NPF SOPs.
• Coordinate and review and approve deviations, corrective and preventative actions, and change controls.
• Monitoring stock transfers.
• Maintaining retained samples according to GMP.
• Review and approve release and stability test results
• Maintain QC master files for all registered products.
• Management representative for the site quality management system.
• Hire and supervise Quality assurance/ Quality control staffs.
• Review and approval of packaging Design and development for new product design and development.
• To monitor and implement overall site Quality Operation.
