Reviewer Qc Microbiology

Department
- GOA QC
- Job posted on
- Feb 12, 2025
- Employment type
- P-P8-Probationer-HO Executive

Please enter job description:

- The review includes verifications and approved of test reports of Raw materials, In-process Samples, finished, Stability, Calibration & Validation, Environmental monitoring reports of production & microbiology lab, Identification of microorganism (Vitek 2 compact), Biological indicator, BET, sterility, water reports etc.
- Review of analytical documents and approval through LIMS.
- Protocol and summary report preparation of method validation of MLT, BET, STERILITY and other miscellaneous study protocols, summary reports etc.
- Qualification and validation documents reviewed.
- Handling & Investigation of Microbiological Non-conformances like OOAC, OOAL, OOS and other errors related to microbiological incidences, transcription errors etc.
- Software handlings like LIMS, SAP, Ample logic, DMS etc.
- Ensure adherence of cGMP & cGLP regulatory requirement as per standard operating procedure & assurance of the same by means of regular monitoring.