In charge Microbiology department

5 - 9 years

0 Lacs

Posted:3 days ago| Platform: Shine logo

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Work Mode

On-site

Job Type

Full Time

Job Description

As an In charge of the Microbiology Department in the pharmaceutical industry with 5+ years of experience, your role involves performing microbiological testing of raw materials, in-process samples, finished products, and environmental samples to ensure compliance with GMP and regulatory standards. Key Responsibilities: - Perform microbiological analysis of raw materials, in-process samples, and finished products. - Conduct environmental monitoring of production and microbiology areas (air, surface, personnel monitoring, etc.). - Perform tests such as Sterility Testing, Endotoxin Testing (LAL test), Microbial Limit Test (MLT), and Water Testing (RO, Purified, WFI). - Prepare and maintain culture media, reagents, and microbial cultures. - Identify and maintain microbial cultures used in routine analysis. - Calibrate and maintain microbiology laboratory instruments (autoclave, incubator, laminar air flow, etc.). - Maintain proper documentation as per GMP guidelines (records, logbooks, and data sheets). - Participate in validation activities (media fill, cleaning validation, environmental validation). - Ensure adherence to safety and aseptic practices in the microbiology lab. - Report out-of-specification (OOS) and deviations to the QC Head and participate in investigations. Qualifications Required: - M.Sc. in Science, with a focus on Microbiology. - Background in manufacturing and analytical techniques. - 5+ years of relevant experience in the regulated pharmaceutical industry, specifically including Quality Control Microbiology Lab. - Experience with Health Canada GMP inspections and third-party audits. Skills Required: - Knowledge of cGMP and GLP practices. - Familiarity with regulatory requirements (FDA, WHO, GMP). - Strong analytical and documentation skills. - Attention to detail and adherence to lab safety protocols. This is a full-time position based in Pune, Maharashtra, requiring reliable commuting or planning to relocate before starting work. A Master's degree is preferred, and a total of 5 years of work experience is required, with specific experience in Microbiology (5 years) and Pharmaceutical (3 years).,

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