Key Responsibilities

Microbiology Laboratory Management

- Lead and supervise microbiology laboratory operations.
- Ensure timely testing and release of raw materials, water samples, in-process samples, finished products, and environmental monitoring samples.
- Review and approve microbiological test results, reports, protocols, and investigations.
- Ensure laboratory compliance with cGMP, GLP, data integrity, and regulatory requirements.

Environmental Monitoring & Contamination Control

- Manage environmental monitoring programs for classified manufacturing areas.
- Oversee personnel monitoring, air monitoring, surface monitoring, and compressed gas monitoring activities.
- Trend environmental monitoring data and identify adverse trends.
- Develop and implement contamination control strategies.

Water and Utility Monitoring

- Manage microbiological monitoring of purified water, WFI, clean steam, compressed air, and other critical utilities.
- Investigate excursions and implement effective CAPA.
- Review utility trend reports and recommend improvements.

Sterility Assurance

- Support aseptic manufacturing operations and media fill programs.
- Review sterility testing and bacteriological assessments.
- Participate in contamination investigations and risk assessments.




- Ensure compliance with sterile manufacturing requirements and regulatory expectations.

Method Validation and Qualification

- Oversee microbiological method validation, verification, and transfer activities.
- Support qualification of equipment and laboratory systems.
- Review microbiological aspects of facility and utility qualification.

Investigation and CAPA Management

- Lead investigations related to OOS, OOT, deviations, environmental monitoring excursions, and contamination incidents.
- Perform root cause analysis and establish effective corrective and preventive actions.
- Monitor CAPA effectiveness and closure.

Regulatory Compliance and Audits

- Ensure compliance with USFDA, MHRA, EU GMP, WHO, PIC/S, and local regulatory requirements.
- Act as SME during regulatory inspections, customer audits, and internal audits.
- Prepare audit responses and monitor implementation of commitments.

Team Leadership

- Manage and develop microbiology team members.
- Conduct training and competency assessments.
- Drive a culture of quality, compliance, and continuous improvement.

Interested candidates can send resume to [email protected]

Job Location: Guwahati , Assam

📌 Microbiology Manager (Guwahati)
🏢 SUN PHARMA
📍 Guwahati