Manager – Microbiology

Experience: 13 to 17 years

Location: R&D; – ZRC|Fill & Finish, Ahmedabad, Gujarat, India

Skills: Microbiology, Sterility testing, Bio-burden testing, Endotoxin testing, Water sampling, GLP practices, Analytical method validation, Method transfer, Regulatory guidelines, cGMP, Team management, Leadership, Cross-functional collaboration, Problem-solving, Decision-making

Position Title:
Manager – Microbiology
Department:
Quality Control – Microbiology
Location:
Unit 9 (Fill & Finish)
Qualification & Experience
Education:
M.Sc. in Microbiology
Experience:
13–17 years of relevant experience
Industry Experience:
Mandatory experience in sterile injectable manufacturing facility
Leadership:
Proven experience in leading and managing microbiology teams
Key Responsibilities
1. Microbiology Operations
• Ensure all microbiological testing is performed in accordance with approved SOPs and written procedures
• Ensure timely and accurate reporting of microbiological results to Quality Assurance
• Oversee routine microbiological analysis including:
• Sterility testing
• Bio-burden testing
• Endotoxin testing
2. Environmental Monitoring & Water Systems
• Ensure environmental monitoring (EM) is carried out as per defined procedures and schedules
• Monitor and manage water sampling and analysis (PW, WFI) as per planning
• Review and ensure compliance of EM and water data
• Prepare and oversee trend analysis for:
• Environmental monitoring
• Water system performance
3. Equipment & Laboratory Management
• Ensure calibration, qualification, and maintenance of microbiology laboratory instruments and equipment
• Maintain laboratory compliance with GLP practices
• Ensure all laboratory documentation is accurate and audit-ready
4. Validation & Qualification
• Review and ensure execution of:




• Analytical method validation
• Method transfer and verification
• Ensure compliance with current regulatory guidelines and recommendations
• Plan and oversee:
• Area qualification of cleanrooms
• Water system qualification (PQ stages)
5. Compliance & Regulatory
• Ensure strict adherence to cGMP and GLP requirements within the microbiology section
• Maintain lab readiness for regulatory inspections and audits
• Identify and implement continuous improvement initiatives
6. Documentation & Review
• Review and approve:
• QC documents
• SOPs
• Protocols and reports
• Investigations (OOS, OOT, deviations)
• Participate in and support cross-functional investigations
7. Cross-Functional Coordination
• Coordinate with departments such as:
• Production
• Quality Assurance
• Engineering
• Ensure support for microbiology-related activities across functions
8. Team Management
• Lead, mentor, and develop the microbiology team
• Ensure proper training and skill development of team members
• Designate and authorize secondary responsible personnel for each functional area
• Allocate tasks and monitor team performance
Key Skills & Competencies
• Strong knowledge of sterile manufacturing and aseptic practices
• Expertise in environmental monitoring and water systems
• In-depth understanding of regulatory guidelines (USFDA, EU GMP, WHO, etc.)
• Strong analytical, problem-solving, and decision-making skills
• Effective team management and leadership skills
• Positive communication and cross-functional collaboration ability
Key Performance Indicators (KPIs)
• Timely completion and reporting of microbiological tests
• Compliance with EM and water monitoring schedules
• Audit and inspection outcomes
• Effectiveness of investigations and CAPAs
• Laboratory compliance with GMP/GLP standards
• Team performance and capability development

📌 Manager – Microbiology (Ahmedabad)
🏢 Zydus Lifesciences
📍 Ahmedabad