• Work allocation for sampling , analysis related to microbial testing based on requirement and plan for sampling and analysis of finish products, & (test procedures and SOPs, and review of analysis data generated through LIMS & SAP systems / modules and report to HOD-QC ). • Review and approval of analysis data of microbial analysis for stability and API analysis data whenever required. • Responsible for calibration, maintenance and trouble shooting of instruments and ensure the calibration and maintenance performed as per schedule and laid down SOPs with documentation and updation of instrument calibration status tag. • Preparation / Review of test protocols, validation protocols and SOPs related to microbiology section. • Ensure timely availability of media, microbial cultures, glassware, chemicals, consumables, parts, stationary and spares and other material required for microbiology lab. • Review of method validation / verification and preparation of Protocol/reports. • To ensure every analysis is to be done as per predefined specification and method of analysis. • To ensure and maintain records of Training and analyst Qualification . • To ensure all records / documents are maintained in compliance to regulatory requirements. • To ensure all the entries, records and results are in line with current SOP, specifications & STPs, review and approval of certificate of analysis of Microbiological reports. • To report and investigate report any incidents / Deviation/ discrepancy in laboratory analysis and inform to HOD-QC. • To ensure that the instrument history record is maintained for all instruments. • Ensure the Qualification / Validation of all instruments in microbiology laboratory. • To ensure monthly project creation and verification of back up restore of electronic / software generated analysis data. • Co-ordinate with service engineer regarding break-down and preventive maintenance of equipments or facility. • Ensure the validity of media preparation and growth promotion test. • Ensure purified water and Environmental monitoring as per schedule and records shall be maintained as per SOP. • Microbiological analysis, review and approval of protocol and of reports. • Review of trend data of water samples, finished products and environmental monitoring. • Ensure CFR 21 part -11 compliance and follow good laboratory practices followed during analysis and ensure proper, integration and online and periodic review for analysis data electronic data to maintain proper data integrity. • Ensure that all documents / records required for Regulatory Compliance are maintained properly. • Review SOP’s for regulatory compliance and inline with the current practice. • To ensure the analytical documents like specification, protocol, STP, are prepared as per SOP. • Ensure timely report and completion of NQI,QI, OOS, OOT, deviation, customer / market complaint investigation and change control. • Ensure all issues related to completed batches are resolved and documents are transferred to QA. • To maintain instruments logbooks properly as per analysis. • To maintain the GLP and GMP practices & ensure standards procedures in Quality Control laboratory followed effectively. • To review the Standard Operating procedures, work sheets/protocols of Hold time / stability / validation / qualification and other relevant documents of Quality control department. • To ensure awareness for safe handling of culture and media handling • To ensure the safe disposal of the media and culture waste. • To educate and train the workmen and implement the safe handling of media, reagents, cultures, chemicals, gas cylinder and laboratory instruments to prevent the accidents. • To ensure the storage of lab. Chemicals and test samples at proper place with segregation to prevent accidents. • To co- ordinate with QA department for cGMP system • To co -ordinate with production department for planning/clubbing of analysis.. • Inform / discuss with Department Head for any breakdowns, Deviations, quality issues, etc. for investigation and documentation. • To ensure the storage of lab chemicals and test samples at proper place with segregation to prevent accidents.