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Team Member
3 months ago
- Follow SOPs for conducting QC operations as per requirements.
- Perform Environmental Monitoring (EM) activities in manufacturing areas and the microbiology laboratory.
- Prepare water trends and EM trends on a monthly, semiannual, and annual basis.
- Conduct microbial sampling for water for injection, purified water, potable water, and pure steam.
- Conduct sampling for compressed gases and nitrogen gases.
- Perform water analysis on water samples according to procedures.
- Decontaminate released media plates and biological indicators according to procedures.
- Operate steam sterilizers, decontamination autoclaves, and hot air ovens.
- Verify media stock and other lab consumables related to microbiology.
- Release microbial analysis plates and tubes (water analysis, environmental monitoring, bioburden, MLT, or any microbial activity plates and tubes) and update results in LIMS while compiling COAs.
- Perform daily calibrations of balances and pH meters.
- Prepare disinfectants and perform equipment cleaning and monitoring.
- Carry out Media Preparation, sterilization, and GPT for Ready To Use/in-house prepared media.
- Ensure that all equipment and instruments are in a validated and calibrated state.
- Participate in Media filled vial observations.
- Maintain media/cultures properly in the microbiology laboratory.
- Perform microbial examination of non-sterile products (Microbial Limit Test) and method validation.
- Conduct in-process bioburden testing, method validation, and cleaning validation samples.
- Enumerate and inoculate biological indicators (BI's).
- Perform container closure integrity testing for media fill vials after release.
- Isolate, subculture, and identify environmental isolates using the Vitek 2 identification system.
- Escalate issues to Team Leader/HOD.
- Perform any other assignments given by the Team Leader/HOD.
BSC - Microbiology & MSC - Microbiology
