Microbiologist | Gufic Group | Navsari

Job Description

Roles and Responsibilities:

• Responsible for Daily sampling and analysis of in-process and water samples as per the procedure.
• Responsible For Preparation and pouring of media plate.
• To perform BET (Bacterial Endotoxin Test) test and Microassay.
• To perform a Sterility Test, Bioburden, and MLT (Microbial Limit Test) or water and product.
• To Perform Growth Promotion / Inhibitory / Indicative Property Test Of Media.
• To report results of the analysis in raw data sheet issued.
• Entry and maintain all micro-related logbooks.
• To Follow the QMS (Quality Management System) system (Out of Specification, Deviation, Incident)
• To participate in validation activity.
• Observation and review of media fill the container.
• To perform environmental monitoring in a clean room as per standard operating procedure.
• To run the autoclave cycles and unload the loads as per SOP (Standard operation procedure).
• To monitor incubator condition daily and record, take a printout, and verify.
• To maintain the GLP (Good laboratory practices) and follow GDP (Good documentation practices) in the laboratory.
• To run washing and drying machine.
• To raise Out of Specification if noticed.
• Responsible to perform analysis of Analytical method Validation, Analytical method Transfer, reconstitute Solution stability, and additional analytical test required as per party quarry reply.
• Responsible for the preparation of Analytical method validation protocol, raw data, and report.
• Responsible for review of Analytical method validation protocol, raw data, and report.
• Responsible for preparation of Excel sheet preparation of analytical method validation, method transfer, and Reconstitute Solution Stability study.
• Responsible for planning of method validation activity. Requirement of the sample, standard, reference standard, column, and the instrument provides to the analyst.
• Responsible for training provided to the analyst for analytical method validation and method transfer SOPs (Standard operating procedures).
• Responsible to control and maintain records like protocols, raw data, and reports of method validation, method transfer, and reconstitute solution stability. Analysis records, usage log books, and status labels during day-to-day Analysis of validation.
• Any other Responsibility assigned by the HOD (Head of Department).
• To assist the HOD (Head of Department) in the preparation of regulatory inspection..

Desired Candidate Profile

• Candidate Should be From Pharma Background
• Good Verbal and Written Communication

Qualification: B.Sc Microbiology, MS/M.Sc Biotech, Microbiology