Senior Officer-Micro
Amneal Pharmaceuticals
Date: 2 weeks ago
City: Ahmedabad, Gujarat
Contract type: Full time
Job Description
Responsible for line clearance activity before commencing the different operations like dispensing, manufacturing, filling, inspection, sealing, labelling, and packing.
Responsible for Process validation, cleaning validation/verification, hold time study, media fill & routine batch sampling as per protocol/SOP.
Responsible for review of executed BMRs and BPRs.
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 of planner and calibration certificates.
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.
Responsible to monitor cGMP compliance at shop floor.
Responsible to review the different type of print outs i.e CIP, SIP, autoclave, filter integrity etc..
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.
Review of Media fill CD.
Review of Visual inspector qualification record.
Activities other than defined in the Job responsibility are to be done, as per the requirement of HOD, by following HODs instruction and guidance.
To perform aseptic behavior/practice monitoring of operators (while working inside aseptic process area) during each aseptic batch (GMP batch) as per SOP.
Skills
Skills :
Conducting sterility testing, endotoxin testing, and microbial contamination control. Monitoring and documenting environmental conditions (temperature, humidity, microbial contamination, airborne particulates).
Responsible for line clearance activity before commencing the different operations like dispensing, manufacturing, filling, inspection, sealing, labelling, and packing.
Responsible for Process validation, cleaning validation/verification, hold time study, media fill & routine batch sampling as per protocol/SOP.
Responsible for review of executed BMRs and BPRs.
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 of planner and calibration certificates.
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.
Responsible to monitor cGMP compliance at shop floor.
Responsible to review the different type of print outs i.e CIP, SIP, autoclave, filter integrity etc..
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.
Review of Media fill CD.
Review of Visual inspector qualification record.
Activities other than defined in the Job responsibility are to be done, as per the requirement of HOD, by following HODs instruction and guidance.
To perform aseptic behavior/practice monitoring of operators (while working inside aseptic process area) during each aseptic batch (GMP batch) as per SOP.
Skills
Skills :
Conducting sterility testing, endotoxin testing, and microbial contamination control. Monitoring and documenting environmental conditions (temperature, humidity, microbial contamination, airborne particulates).
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