Senior Manager- Quality Control (Microbiology)

Roles & Responsibilities:

1. Microbiological Risk Management:

   Identify, assess, and control microbiological risks in raw materials, production processes, utilities, and finished products. Develop and implement effective control strategies.

2. Laboratory Operations Management:

   Lead and oversee all microbiology laboratory activities including:
• Routine testing of raw materials, in-process, and finished products.
  
• Method validation/verification and equipment qualification.
  
• Cleaning validation and environmental monitoring (EMPQ).
  
• Microbial identification and trending of environmental monitoring results.
  

3. Technical Problem Solving:

   Investigate and resolve laboratory technical issues, out-of-specification (OOS) results, and environmental monitoring (EM) nonconformances. Drive root cause analysis and implement effective CAPAs.

4. Team Leadership & Training:

   Supervise, mentor, and train microbiologists and lab technicians. Foster a culture of continuous learning and ensure adherence to microbiological best practices.

5. Regulatory Compliance:

   Ensure all microbiology operations comply with cGMP, regulatory, and corporate quality standards. Manage deviations, change controls, and CAPAs within the Microbiology function.

6. Documentation & Reporting:

   Prepare, review, and update SOPs, protocols, and reports related to microbiological activities. Maintain robust documentation practices aligned with audit readiness.

7. Data Management & Analysis:

   Oversee data recording, management, and storage systems (LIMS preferred). Ensure accuracy, traceability, and accessibility of microbiological data. Analyze trends to identify process improvements and contamination risks.

8. Audit & Client Interaction:

   Act as a subject matter expert (SME) for microbiology during regulatory inspections and client audits (including USFDA, MHRA, etc.). Prepare audit responses and ensure compliance readiness.

Preferred Candidate Profile:

• Strong exposure to

  sterile microbiology

  in a

  pharmaceutical manufacturing environment

  (Injectables / Parenterals).

• Hands-on experience in facing USFDA audits

  and handling audit queries independently.
• Proven experience in

  Contamination Control Strategy (CCS)

  implementation for sterile areas.
• Sound understanding of GMP, GLP, and regulatory requirements for sterile product manufacturing.
  
• Excellent leadership, analytical, and communication skills.
  

Education & Experience:

• Qualification:

  M.Sc. / M.Tech in Microbiology, Biotechnology, or related field.

• Experience:

  15-21 years in sterile pharmaceutical microbiology with leadership exposure.