Responsible to perform sterility testing, bacterial endotoxins testing, LBPC and bioburden testing of raw material, in-process, packing material, finished products, Stability samples and other miscellaneous samples
- Responsible for water and pure steam sampling and analysis as per defined schedule.
- Viable and non-viable monitoring in clean area of microbiology lab as per the defined schedule.
- Responsible for Media fill vial observations and CCIT testing.
- Responsible to identify and maintain EM Isolates, operating VITEK-2, isolates trend preparation.
- Responsible for biological indicator analysis and issuance and other miscellaneous sample/protocol based studies execution.
- To handle and distribute various samples received for microbiological analysis. To maintain the log book for the same.
- Responsible for GPT Analysis and culture handling.
- Responsible to participate in qualification, requalification, area qualification activities.
- Responsible to co-ordinate with cross functional department personnel for timely completion of qualification / Validation / Re-qualification activity.
- Responsible for daily monitoring of temperature, differential pressure,
relative humidity of clean areas.
- Verification and approval of temperature records of BOD incubators, deep freezers, walk-in incubators and cooling cabinets.
- To perform calibration/qualification of instruments/equipment as per pre define schedule
- EM, tested sample releases and recording, data update in LIMS.
- Responsible to handle QMS related activities including preparation/revision of standard operating procedures, Investigations, protocol preparations, report preparation.
- Responsible for reporting any OOS, Deviation to In-charge.
- To maintain the inventory of microbiological media, log and status labels for all such items and reconciliation record of items / media.
- Responsible for decontamination of media, cultures and other microbiological waste.
- Activities shall be performing apart from assigned job responsibilities as per the instructions of concerned HOD/In-charge