In charge of Microbiology department
5 days ago
Designation - In charge of Microbiology Department
Industry - Pharmaceutical
Experience - 5+ Years
FDA Approval Micrologist
Job Summary:
Roles And Responsibilities-
The Microbiologist is responsible for 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.
M.Sc. in Science, with Micrology
Background in manufacturing and analytical techniques
5 + years relevant experience in the regulated pharmaceutical industry, specifically including Quality Control Microbiology Lab
Experience with Health Canada GMP inspections and third-party audits
FDA Approval Certificate
- 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.
Job Type: Full-time
Pay: ₹40, ₹60,000.00 per month
Benefits:
- Health insurance
- Provident Fund
Ability to commute/relocate:
- Pune, Maharashtra: Reliably commute or planning to relocate before starting work (Required)
Education:
- Master's (Preferred)
Experience:
- total work: 5 years (Preferred)
- Microbiology: 5 years (Required)
- Pharmaceutical: 3 years (Required)
License/Certification:
- FDA Approval Microbiologist (Preferred)
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