Thorough understanding & work experience of
- Environmental Monitoring
- Sterility, Bacterial Endotoxin Test
- Micro Validation
- Plates & Tube Observation and
Key responsibilities & authorities :
> To prepare the media, as and when required.
> To observe the tubes and plates and to supervise the discarding method of the same.
> To perform periodic microbiological tests as per the schedule, as per Standard Operating Procedure (SOP).
> To perform the Bacterial Endotoxin Test as per the schedule.
> To test the material for their pre-sterile bio-burden and to test Raw Material (RM)/ Packing Material (PM) for bio-burden test.
> To co-ordinate with Technical department for any kind of machine related abnormality, which might be affecting the quality of the product, and its microbiological content.
> To take the samples for sterility test and to carry out the sterility testing as per schedule.
> To sign all the documents related to microbiological testing.
> To sign the documents related to sterility testing.
> To analyze water samples for pH, conductivity, Bacterial Endotoxin Test (BET), bio-burden, Total Organic Carbon (TOC), bio- assay, pathogens, Thermophiles, chlorides, hardness, silt density index etc.
> To analyze the samples of water system after maintenance work and forward the report to executive of department for review.
> To maintain and update stock record of Limulus Amoebocyte Lysate (LAL) reagents.
> To qualify the personnel to enter in to the clean.
> To keep track of requirement for procurement and give monthly requirement to executive.
> To qualify the prepared media for growth promotion test.
> To perform gram staining of daily-observed colonies and identify them on BBL crystal.
> To perform the microbiological analysis of stability sample as per daily plan of work & in line with standard operating procedure.
> To prepare Contact plate for routine monitoring.
> To perform the validation as per the laid down protocol.
> To prepare pure culture for routine use.
> To maintain and update media stock record formats.
Required criteria :
> Must have experience in Parenteral / Injectables only.
> Must have good communication.
Education Qualification :
M.Sc / B.Sc
Claris Lifesciences is an Indian sterile injectables pharmaceutical company with a... market presence across 100 countries worldwide. We primarily manufacture and market products across multiple markets, and therapeutic segments. A significant majority of these products are generic drugs that are capable of being directly injected into the human body and are predominantly used in the treatment of critical illnesses. Read full description