Job Summary:

The Senior QC Microbiologist is responsible for overseeing and executing advanced microbiological testing activities to ensure the quality, safety, and compliance of products. This role involves supervising routine microbiological operations, monitoring environmental controls, ensuring regulatory compliance, investigating deviations, and supporting continuous improvement initiatives across production and quality systems.

Key Responsibilities

· Microbiological Testing & Analysis

Perform and supervise microbiological testing of raw materials, in-process samples, finished products, water systems, and utilities using standard techniques (plate counts, microbial identification, endotoxin testing, sterility testing, etc.).

Review and approve test results to ensure compliance with internal specifications and regulatory requirements.

· Environmental Monitoring

Lead environmental monitoring programs for cleanrooms, controlled areas, air, surfaces, and water systems.

Trend and analyze environmental data to identify potential contamination risks and recommend preventive actions.

· Aseptic & GMP Practices

Ensure strict adherence to aseptic techniques, GMP, and microbiological best practices during sampling, testing, and documentation.

Act as a subject-matter expert for aseptic behavior and contamination control.

· Deviation, Investigation & CAPA

Lead investigations related to out-of-specification (OOS), out-of-trend (OOT), deviations, and microbial contamination events.

Perform root cause analysis and implement CAPA in coordination with QA and Production teams.

· Documentation & Compliance

Review,



prepare, and maintain SOPs, test methods, validation protocols, reports, and logbooks.

Ensure laboratory compliance with GMP, GLP, regulatory guidelines, and internal quality systems.

Support internal, customer, and regulatory audits.

· Method Validation & Equipment Qualification

Lead or support method validation, method transfer, and qualification of microbiological equipment and instruments.

Ensure calibration and maintenance of microbiology lab instruments.

· Team Leadership & Training

Guide, mentor, and train junior QC microbiologists and technicians on testing techniques, GMP, and documentation.

Support skill development and performance improvement within the QC microbiology team.

· Cross-Functional Collaboration

Work closely with Production, QA, Engineering, and EHS teams to improve processes, reduce contamination risks, and enhance overall product quality.

Qualifications & Experience

Master’s Degree in Microbiology or a related discipline.

6 Months – 5 years of experience in QC Microbiology within pharmaceutical, chemical, API, or manufacturing environments.

Strong knowledge of GMP, environmental monitoring, sterility assurance, and regulatory requirements.

Proven experience in handling audits, investigations, and CAPA.

Excellent analytical, documentation, leadership, and communication skills.

Job Types: Full-time, Permanent

Pay: ₹20,000.00 - ₹34,000.00 per month

Advantages:

- Provident Fund

Education:

- Master's (Required)

Experience:

- Quality control: 1 year (Preferred)

Work Location: In person

📌 QC Microbiologist (India)
🏢 Sisco Research Laboratories
📍 India