QC - Microbiology

2519Role & responsibilities

• Experienced in performing Microbial Limit Tests (MLT), Sterility Testing, Bacterial Endotoxin Test (BET), and Preservative Efficacy Test (PET) in accordance with approved procedures and GMP requirements.
• Hands-on experience in media preparation, sterilization, growth promotion testing, media hold-time studies, and culture handling, including culture dilution, maintenance, and preservation.
• Experienced in environmental monitoring of pharmaceutical microbiology areas, including sampling, testing, result evaluation, and trend analysis.
• Proficient in water analysis, including microbiological examination of pharmaceutical water systems and interpretation of results against approved specifications.
• Experienced in bioassay testing and microbiological testing activities as per approved methods and protocols.
• Hands-on experience in disinfectant efficacy studies and evaluation of disinfectant effectiveness against specified microorganisms.
• Experience in autoclave validation, routine monitoring, and validation-related microbiological activities.
• Responsible for instrument calibration, qualification support, and maintaining laboratory equipment records in compliance with GMP requirements.
• Experience in method validation/verification and preparation of validation protocols, reports, and supporting documentation.
• Experienced in audit management and regulatory inspection support, including USFDA, WHO-GMP, NABL, and EU-GMP audits/inspections.
• Ensure adherence to approved SOPs, specifications, test methods, safety requirements, data integrity principles, and Good Documentation Practices (GDP).
• Capable of coordinating routine microbiological testing, investigations, documentation, compliance activities, and laboratory quality-system requirements.
• Interested Candidate can contact - [phone removed]