Quality Control (Microbiology): Officer –

- Environmental Monitoring (EM)

- Routine EM Sampling Execution: Conduct scheduled viable and non-viable Environmental Monitoring across cleanrooms (Grades A, B, C, and D) and utility points using air samplers, settle plates, contact plates, and surface swabs.
- Personnel &
- Gowning Monitoring: Perform routine aseptic personnel monitoring (finger dabs, gown plates) for cleanroom operators exiting Grade A/B aseptic suites to verify gowning qualification compliance.
- Cleanroom &
- Utility Qualification Support: Execute environmental sampling during cleanroom requalification, HVAC shutdown restarts, media fill simulations (Aseptic Process Simulations), and compressed gas/water system validations.
- Incubation &
- Plate Enumeration: Manage sample receipt, dual-temperature incubation regimens, colony-forming unit (CFU) enumeration, and morphological characterization of recovered microbial isolates.
- Microbial Identification &
- Sub-culturing: Perform Gram staining, sub-culturing, and automated/biochemical microbial identification (e. g., VITEK, MALDI-TOF) for Grade A/B recoveries and action-level excursions.




- ALCOA+ Data Integrity &
- LIMS Entry: Record raw sampling logs, plate counts, incubator charts, and LIMS entries contemporaneously, maintaining strict adherence to ALCOA+ data integrity principles.
- EM Trend Analysis &
- Reporting: Compile weekly, monthly, and quarterly EM trending reports to track microbial flora shifts and alert/action limit patterns across manufacturing zones.
- QMS Excursion &
- OOS/OOT Investigations: Initiate and drive Out-of-Trend (OOT), Out-of-Limit (OOL), and EM excursion investigations, conducting root cause analysis (RCA) and coordinating sanitization CAPAs with Production.
- Audit &
- EU Annex 1 Readiness: Maintain EM maps, sampling schedules, disinfectant efficacy records, and raw data logs in an audit-ready state for regulatory inspections ( USFDA, EU Annex 1, WHO ).
- Aseptic Discipline &
- EHS Compliance: Enforce strict multi-stage cleanroom gowning discipline, biosafety waste autoclaving/disposal protocols, and laboratory Environmental Health &
- Safety (EHS) standards.

📌 QC Micro - Officer (Daman)
🏢 USV Private
📍 Daman