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Quality

• Schedule, prepare protocol/reports, and conduct process and cleaning validation.
• Provide ongoing training, motivation, coaching, support, and correction to employees to ensure that quality standards are met.
• Responsible for investigation of complaints and recalls in coordination with other departments.
• Issue controlled documents, e.g., specifications, BMRS, CAPA forms, Deviation reports, QC reports, preventive maintenance forms, facility layouts, SOPs, protocols, etc.
• Collect and compile statistical quality data, keeping accurate record of the same (APQR).
• Monitor cleaning of warehouses, temperature mapping, and environment monitoring.
• Document and report quality issues to the team leaders and section head.
• Verify the received materials on receipt and ensure that they adhere to the defined standard specifications.
• Preparation of documents required for regulatory affairs.
• Monitoring and control of the manufacturing environment.
• Checking of overprinted details and proof checking.
• Line clearance during product changeover.
• Compliance of audit observations.
• Ensure basic norms of cGMP are being followed at all times.
• Ensure availability and implementation of updated and approved SOPs in manufacturing, quality control, Engineering and warehouse areas. This includes conformance of activities with SOPs and any need to modify.
• To check the cleanliness of the shop floor and auxiliary area.
• Countercheck the in-process parameters.
• Ensure calibration of equipment/instruments is regularly done.
• Ensure the manufacturing process is validated and carried out as per instructions in the BMR.
• Ensure health, safety, and environmental norms are being followed.
• Check status labels and labeling of containers, equipment, and materials.
• Online documentation and timely entries of all operations/activities.
• Participate in validation, qualification, and performance verification.
• Perform quality assurance rounds (Gemba walks).
• Review and verification of different logs of production, packing, and store areas.
• To review the finished goods receipt (BSR), storage, control, and dispatch.
• To participate in external calibration and thermal mapping as per schedule.
• Ensure that FEFO and FIFO are followed.
• Perform sampling of bulk and retention samples.

Health and safety

• Identify, assess, prioritize, and control risks arising from operations/activities in relation to the impact on the health and safety of all staff, contractors, and visitors.
• Ensure that the work environment is safe and any health and safety risks are documented and followed by all staff through appropriate toolbox talks.

Authorities:

• Issuing controlled documents.
• Deviation reporting on non-conforming activities.
• Line clearance for all production activities.
• Approval/rejection on receipt of starting materials.