Senior Manager- Quality Control

1 week ago

Pune, Maharashtra, India Enzene Full time

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:

  3. Routine testing of raw materials, in-process, and finished products.

  4. Method validation/verification and equipment qualification.
  5. Cleaning validation and environmental monitoring (EMPQ).

  6. Microbial identification and trending of environmental monitoring results.

  7. 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.

  8. Team Leadership & Training:

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

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

    Prepare, review, and update SOPs, protocols, and reports related to microbiological activities. Maintain robust documentation practices aligned with audit readiness.
  11. 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.
  12. 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.

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