Microbiologist Required (For Shifts) in a Pharma

Job Description
  • 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

Functional Area:Other

Role:Other

Keyskills

Bacterial Endotoxin Test, Water Validation, Staining, Bet, Raw Water, LAL, BBL, micro, microbiology, bio – burden

Education

UG:B.Sc – Microbiology

PG:MS/M.Sc(Science) – Biotechnology, Microbiology