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.

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