Responsibilities
- Reporting / review of microbiology results of Raw Materials, Packing Materials, In-process Materials and Finished Products as required.
- Review and approval of Microbiological analysis reports [Water, Microbial monitoring of clean rooms, MLT and BET].
- Preparation of SOP's related to QC Microbiology.
- Maintenance of media stock and related GPT records.
- Implementation of Good Microbiological Laboratory Practices at work.
- Review of microbial test results of water samples as required.
- Maintenance of reference standard cultures / subcultures; preparation and maintenance of working cultures as applicable for microbiological testing.
- Preparation of miscellaneous validation protocols / reports as required.
- Preparation of MLT & BET method validation protocols / reports as required.
- Executing bacterial endotoxin testing / review of analytical data and related documentation.
- Trending of microbiological results in terms of microbial monitoring of clean rooms / purified water results.
- Equipment qualification / requalification within Microbiology Lab.
- Reviewing of PRP's and CCP's as per relevant procedures.
Skills: validation,microbiology,testing,analytical data review,validation protocols,sop preparation,microbial monitoring,good laboratory practices,analysis reports
