Quality Assurance Associate - Microbiology Reviewer

Role Summary : Team Member QA˗ Microbiology ensuring overall compliance of Microbiology lab in terms of Environmental monitoring, Water testing, product testing, method validations, instrument and equipment calibrations/PM/RQ management, media and culture management and QMS elements. Primary Responsibilities: - To Perform test-level and sample-level LIMS analytical data review and approval for: - Bioburden/In-process: Perform the verification of Bioburden/In-process, contamination check plates and review the relevant test data. - MLT (Microbial Limits Testing): Perform verification of TAMC/TYMC, test for specified organisms' plates/tubes, etc. and review the MLT data. - Utilities (Water & Process Gases): Perform verification of test samples or plates PW/WFI/Clean Steam/Compressed Air/ Nitrogen /CO2/O2 sampling plan, locations, volumes, media, incubation, alert/action management and review all the test parameters. - To review the Water chemical and Microbial analysis data in LIMS/ non-LIMS. - BET (Bacterial Endotoxin Testing): Review and approval of gel-clot /turbidimetric /chromogenic test reports validation status, standard curves, inhibition/enhancement Nexus-200 setup and audit trail review for KTA instrument. - Sterility: To perform verification of sterility test tubes and review of sterility test data. - CCIT (microbiology-relevant aspects): review of protocol/report linkage where applicable (e.g., microbial ingress risk assessments). - Environmental Monitoring (EM) in LIMS: Perform plates/swabs verification for active air, settle plates, surface/contact plates, personnel monitoring map locations, frequencies, routes, recovery rates, organism ID. - Verify acceptance criteria per specification/SOP/STP ensure calculation accuracy and traceable raw data (plates, colony counts, instrument outputs, metadata). - Review of daily calibration/verification and audit trails of Microbiology Instruments. - Review of Temperature monitoring data of incubators/walk in Chambers. - Review of Non-Viable Particle count Monitoring Data in LIMS/ Non-LIMS. - Review of all Microbiology related SOP's, protocol and summary reports. - To support Microbiology or other Cross functional teams during qualification/ re-qualification of facilities and utilities. - To Ensure the Microbiology function is consistently prepared for regulatory and customer inspections, and actively contribute in inspections involving microbiology-related areas. To represent Microbiology Quality Assurance during (Internal/External) audits. - Escalate issues/concerns, w.r.t. non-compliance observed during review/approval and during QC Micro lab/ manufacturing Gemba walk rounds in a timely manner. - To involve in the investigations of deviations/ OOS/OOT/ incidents and facilitate closure of QMS elements such as CAPA, OOS, OOT, OOL, deviations and change controls associated with Microbiology. Secondary Responsibilities: - To ensure compliance in media, culture and other reagent management in Microbiology laboratory with respect to inventory, consumption and regulatory requirement. - To review and approve Batch Analytical Records (BAR) associated with products, media fill or other PPQ batches. - To provide all the Microbiology related data required in Master batch Record or any associated records. - Review of Microbial trends for Environmental monitoring, Utilities (Water and process gases), NVPC, Product bioburden or any other Microbial trends like Annual Product quality Review, PPQ batches data, etc. - To facilitate effective closure of investigations pertaining to Microbiology, sample receipt and cleaning sections i.e. ensure that such investigations are conducted as per scientific rationale and cGMP regulations. - BAR review and support batch release. - LIMS support in static data and master data review and authorization. - OPVM data review and scheduler data review and authorization. - Perform periodic review of record sheets and logbooks for ALCOA+++ compliance. - Review EM, Utilities, and Product trends per frequency and detect special-cause variations recommend actions (expanded monitoring, limit re-evaluation). - Maintain QA dashboards for RFT , on-time approvals , recurrence , trend signals , DI findings - To perform additional responsibilities assigned by the L+1. Educational qualification: M.Sc. in Microbiology or Biotechnology as major preferred Work experience: ਄+ years Skills & attributes: - Strong Aseptic operation skills to ensure aseptic behavior in cleanroom. - Knowledge on cleanroom operations, environmental monitoring techniques. - Knowledge on operation of Labware LIMS and trouble shooting in case of software failure. - Knowledge on operation of various Microbiology Equipment, instruments and handling of breakdowns/preventive maintenance of such equipment/instruments. Skills: Aseptic operation skills, Environmental monitoring techniques Experience: 5.00-7.00 Years