Senior Executive AM - Quality Assurance

Job Description

Job Responsibility

• Responsible for line clearance activity before commencing the different operations like dispensing, manufacturing, filling, inspection, sealing, labeling and packing.
• Responsible for review of executed BMRs and BPRs for batch release.
• Responsible for Process validation, cleaning validation/verification, hold time study, media fill & routine batch sampling as per protocol/SOP.
• Responsible to perform the in-process test at different stages as per batch document/SOP.
• Responsible to review the environment monitoring, water trends.
• Responsible to review the different type planner and calibration certificates.
• Responsible to review the different type of print outs i.e CIP, SIP, autoclave, filter integrity etc.
• Responsible to monitor cGMP compliance at shop floor.
• Responsible to receive the required resources for EM monitoring e.g. plates, samplers, swabs etc. from microbiology lab and after completion of EM monitoring plates, samplers, swabs etc. should be handed over to microbiology lab for further process along with applicable formats which is filled in aseptic area.
• To maintain the Issuance/reconciliation record of items / media for Environment monitoring material e.g. plates, swabs, etc.
• Environmental monitoring of manufacturing clean room area as per the defined schedule.
• Responsible to participate in media fill simulation study.
• Responsible to participate in perform qualification activities of manufacturing area.
• Non-viable particle monitoring of manufacturing clean room area as per the defined schedule.
• Compressed air /nitrogen gas monitoring and Personnel monitoring.
• To perform aseptic behavior/practice monitoring of operators (while working inside aseptic process area) during each aseptic batch (GMP batch) as per SOP.