1.1 To organize microbiology related analysis, supervise the unit operations; ensure compliance to systems at every stage, review of the analytical data and approval/rejection of raw materials, in-process samples, packing materials and product validation and finished products based on the test results.
1.2 Ensure availability of Resources and Training to QC personnel.
1.3 To develop systems and procedures (SOPs) for conducting microbiology functions as per the requirements.
1.4 To ensure the adherence to systems and procedures by all the microbiology personnel.
1.5 To participate in change control procedures on need basis and to initiate change controls
related to QC functions.
1.6 To initiate and investigate Incidents and OOS to take remedial measures.
1.7 To participate and organize analytical method transfers, process validations, cleaning
validations, method suitability studies, area qualifications, various miscellaneous
microbiological validation activities, process simulation studies. Review and approval of
above protocols and reports.
1.8 To review all the raw data, ensure the data accuracy and adequacy as per the approved
1.9 To organize preparation and analysis of trends as applicable and to recommend any changes for the better control of the system.
1.10 To approve STPs, Specifications, preparation of record of analysis and analytical test report.
1.11 To ensure availability of all necessary laboratory resources.
1.12 To coordinate and organize all the calibrations, performance verifications and validations of laboratory instruments / equipment.
1.13 To conduct trainings and to qualify the analysts.
1.14 To participate in internal and external audits on need basis in the organization.
1.15 To develop systems and procedures for conducting QC micro biology functions as per the