Senior Officer, QA Environment Monitoring
Senior Officer, QA Environment Monitoring
Refined job description
ROLE
– Perform line clearance activities before operations such as dispensing, manufacturing, filling, inspection, sealing, labeling, and packing.
– Conduct environment monitoring activities.
– Execute process validation, cleaning validation/verification, hold time studies, media fills, and routine batch sampling per protocol/SOP.
– Perform in‑process testing at various stages according to batch documents/SOP.
– Review environment monitoring and water trend data.
– Review planner and calibration certificates.
– Monitor cGMP compliance on the shop floor.
– Review printouts for CIP, SIP, autoclave, filter integrity, etc.
– Maintain issuance/reconciliation records for environment monitoring materials.
– Conduct environmental monitoring of manufacturing clean‑room areas per schedule.
– Participate in media‑fill simulation studies.
– Perform qualification activities for manufacturing areas.
– Conduct non‑viable particle monitoring of clean‑room areas per schedule.
– Monitor compressed air/nitrogen gas and personnel.
– Review media‑fill CD and visual inspector qualification records.
REQUIREMENTS
– Line Clearance & Batch Record Review – Practitioner
– Regulatory & Compliance Knowledge – Practitioner
Full job description
Responsible for line clearance activity before commencing the different operations like dispensing, manufacturing, filling, inspection, sealing, labelling, and packing.
Responsible to perform the environment monitoring activities
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.
Skills:
Environmental Monitoring (EM) - Expert
In-Process Quality Controls (IPQC) & Sampling - Practitioner
Aseptic Process Simulation (Media Fill) Monitoring - Expert
Line Clearance & Batch Record Review - Practitioner
Good Documentation Practices (GDP) - Practitioner
Regulatory & Compliance Knowledge - Practitioner