- To ensure the clean environment for sterile preparation by implementing the Good Manufacturing Practice (GMP) norms as per the international standards and guidelines.
- To do sampling of Water for Injection (WFI), Double Reverse Osmosis (DRO), Single Reverse Osmosis (SRO), Raw water and pure steam.
- To analyze water samples for pH, conductivity, Bacterial Endotoxin Test (BET), bioburden, Total Organic Carbon (TOC), pathogens, Thermophiles, chlorides, hardness, silt density index etc.
- To analyze the samples of water system after maintenance work and forward the report to Executive for review.
- To maintain and update stock record of Limulus Amoebocyte Lysate (LAL) reagents. To keep track of requirement for procurement of media and give monthly requirement to Executive.
- To prepare different types of media as per instructions of Executive.
- To prepare pure culture for routibio-burdeene use.
- To qualify the prepared media for growth promotion test
- To perform gram staining of daily-observed colonies and identify them on BBL crystal.
- To prepare Contact plate for routine monitoring.
- To maintain and update media procurement and stock record formats.
- To periodically conduct the training programmes for the personnel working in the clean room on health, hygiene and maintenance of clean room environment by following the right procedure of it.
- To collect the validation samples and perform the validation as per the laid down protocol.
- To prepare trends of the results obtained as mentioned in the relevant SOPs
- To perform HEPA filter qualification on periodic basis and as and when required
- To sign the batch release checklist of confirming the EM, water and validation results
- To initiate Deviation or OOS in case of abnormality observed.
Industry:Pharma / Biotech / Clinical Research
Bacterial Endotoxin Test, Water Validation, Staining, Bet, Raw Water, LAL, BBL, micro, microbiology, bio – burden
UG:B.Sc – Microbiology
PG:MS/M.Sc(Science) – Biotechnology, Microbiology