Microbiology Manager

Sun Pharma; Kamrup Metropolitan; On-site; INR 1,200,000 - 1,700,000; Full time

Job summary

Sun Pharma in Guwahati, Assam, is seeking an experienced Microbiology Lab Manager to lead the microbiology laboratory operations and assure timely testing of materials and products. The role requires supervising environmental monitoring programs, reviewing test results, and ensuring adherence to regulatory requirements.

Responsibilities include managing contamination control strategies, CAPA implementation, and ossifying sterile manufacturing support.

Responsibilities

• 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.
• 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.
• 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.
• 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.
• Oversee microbiological method validation, verification, and transfer activities.
• Support qualification of equipment and laboratory systems.
• Review microbiological aspects of facility and utility qualification.
• 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.
• 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.
• Manage and develop microbiology team members.
• Conduct training and competency assessments.
• Drive a culture of quality, compliance, and continuous improvement.

Skills

Microbiology leadership

Regulatory compliance

Team management

Tools

LIMS

Environmental monitoring tools

Job description

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.

Job Location: Guwahati , Assam