We are looking for an experienced Microbiologist to join the Quality Control team at our WHO-GMP certified manufacturing plant. You will be responsible for environmental monitoring, routine microbial testing of raw materials, in-process samples, finished products, and water systems while ensuring strict compliance with cGMP and GLP standards.
Key Responsibilities
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Microbial Testing: Perform TAMC/TYMC, microbial limit testing, and pathogen testing on raw materials, in-process samples, and finished goods as per IP/USP/BP specifications.
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Environmental Monitoring: Conduct routine cleanroom environmental monitoring in manufacturing and packing areas using settle plates, contact plates, air samplers, and surface swabs.
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Water Analysis: Perform routine water microbiology testing for Purified Water (PW) and RO systems, including bioburden analysis and trend maintenance.
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Media Preparation & GPT: Carry out media preparation, sterilization cycles using autoclave, and perform growth promotion tests (GPT) with positive/negative controls.
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Culture Maintenance: Maintain and subculture reference microbial cultures under standard LAF/BSC conditions, ensuring proper identification, storage, and traceability.
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Instrument Handling: Operate, calibrate, and maintain lab equipment including autoclaves, incubators, colony counters, and laminar airflow units as per SOPs.
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Documentation & Compliance: Ensure real-time recording following data integrity and ALCOA+ principles, maintain lab registers, COAs, and logbooks as per Schedule M and cGMP.
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OOS & Investigation: Support investigation of microbial OOS/OOT results, environmental excursion trends, and assist QA in implementing relevant CAPA.
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Experience: 1–6 years of practical experience in the microbiology lab of a pharmaceutical manufacturing plant.
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Education: B.Sc / M.Sc in Microbiology, Biotechnology, or relevant life sciences.
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Skills:
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Hands-on experience with TAMC/TYMC, microbial limits, and cleanroom environmental monitoring.
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Thorough understanding of water testing, autoclave operation, and growth promotion testing.
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Sound knowledge of WHO-GMP, Schedule M, cGMP, and GLP guidelines.
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Familiarity with lab documentation, ALCOA+, and basic computer tools (MS Excel, Word).
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Personal Traits:
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High attention to detail and laboratory discipline.
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Methodical, reliable, and committed to data integrity.
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Good team coordination and problem-solving mindset.
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Competitive salary + performance incentives
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Health insurance (as per company slab)
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PF / ESIC as per norms
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Subsidised meals & company transport
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Stable, quality-driven work culture
