Reviewer QC Microbiology Zydus Group
Zydus Group
Office Location
Full Time
Experience: 3 - 3 years required
Pay:
Salary Information not included
Type: Full Time
Location: Goa
Skills: Microbiology, Calibration, Validation, environmental monitoring, lims, SAP, cGMP, cGLP
About Zydus Group
Job Description
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.,