1.Bacterial endotoxin test, Sterility test and Antimicrobial effectiveness test.
2.Microbiological enumeration tests and Specified microorganisms (confirmatory tests).
3.Analyst qualifications and Estimation and Isolation of lactobacillus sps.
4.Routine water analysis and seasonal water validation and primary qualifications of water systems through Laboratory information management system (LIMS-Water module).
5.Data compilation and making trends for all type of results.
6.Ensuring Media controls like media preparation activities, growth promotion tests and sterility checks for newly received dehydrated media and for each autoclave sterilization lots.
7.Area qualification by microbial techniques like settle plate method, surface monitoring (by contact plate method, and swab method) and volumetric air sampling method.
8.Personnel qualification by Replicate Organism Detection and Counting plate method and swabbing method.
9.Equipment cleaning evaluation techniques, Out of specifications investigations.
10.Ensuring microbiology laboratory activities as per current regulatory requirements.
11.Method suitability and validation of antibacterial & antifungal active pharma Ingredients.
12.Microbiological validation for water system, Determination shelf life of sterile media.
13.Sterility method validation, Hold time limit study for water samples by evaluating TOC and microbial count.
Generic QM experience and successful track record in injectable/formulation are highly preferred. Good documentation and writing skills and Candidates must be self motivated with excellent written and verbal communication skills. Good interpersonal and project management skills are critical for this position.