Quality Assurance Associate - Microbiology Reviewer

Job Description:

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

Qualification & Experience

• Educational qualification: M.Sc. in Microbiology or Biotechnology as major preferred
• Work experience: 4+ years