Urgent Opening
Executive/Manager-Microbiology
(API / Bulk Drug)
API Pharmaceutical Company
Boisar-Palghar MH
Education: ./ . in Microbiology, Chemistry
Experience: 4 to 8 Years
Joining: Immediate Joining is required
FDA-approved shall be an additional advantage
Job description
• Microbiological Testing: Perform routine and non-routine microbiological analysis of raw materials, in-process samples, finished API products, and water systems (potable, purified water, and water for injection).
• Method Validation & Support: Assist in microbiological method validation, microbial limit tests (MLT), bacterial endotoxin tests (BET), and sterility assurance programs where applicable.
• Documentation & Investigation: Maintain laboratory notebooks, logs, and quality formats in line with GDP (Good Documentation Practices). Investigate and document Out-Of-Specification (OOS), Out-Of-Trend (OOT) results, and laboratory deviations.
• Compliance & Audits: Ensure strict adherence to cGMP (Current Good Manufacturing Practices), GLP (Good Laboratory Practices), and global regulatory guidelines (USFDA, EU-GMP, WHO). Experience: Generally ranges from 2 to 6+ years of hands-on experience specifically within API / Bulk Drug or sterile pharmaceutical manufacturing quality control labs. Technical Knowledge: Strong command over aseptic techniques, microbial identification, water testing, and calibration of microbiology laboratory instruments.