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Section Head Microbiology

14-17 years
Not Disclosed
10 Jan. 28, 2025
Job Description
Job Type: Full Time Education: B.Sc,M.Sc,B.Pharma,M.Pharma,LifeScience Graduates Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Section Head - Microbiology
Job Location: Bangalore
Date: 24 Jan 2025


About Syngene

Syngene International Ltd. (www.syngeneintl.com) is a leading innovation-driven contract research, development, and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At Syngene, safety is prioritized equally with business performance, ensuring adherence to safety guidelines and fostering a culture of accountability and integrity.


Core Purpose of the Role

The Section Head - Microbiology will oversee laboratory operations, ensure compliance with regulatory and safety standards, and drive continuous improvement. The role involves guiding employees, maintaining audit readiness, and aligning laboratory practices with industry best standards.


Key Responsibilities

Compliance & Quality Management

  • Provide coaching on compliance issues and prevent noncompliance with cGMP, GDocP, and Data Integrity policies.
  • Ensure adherence to SOPs and approved instructions while mitigating risks of noncompliance.
  • Conduct self-inspections and ensure the laboratory is in an "all-time audit-ready" (ATAR) state for regulatory and client inspections.
  • Monitor laboratory operations to ensure compliance with internal, client, and regulatory audit observations.
  • Identify procedural gaps, infrastructure improvement opportunities, and align practices with regulatory requirements and industry standards.

Employee Training & Supervision

  • Oversee training and qualification of laboratory employees for assigned activities.
  • Guide and support employees in compliance with aseptic practices and laboratory standards.

Continuous Improvement

  • Implement and monitor ideas to reduce laboratory errors and improve productivity.
  • Support the qualification of aseptic manufacturing facilities and ensure alignment with biologics manufacturing standards.

Investigation & Reporting

  • Ensure timely investigation and closure of all Quality Management System (QMS) events.
  • Oversee the implementation and monitoring of CAPAs applicable to the department.
  • Prepare periodic trends, MIS (Management Information System) reports, and take necessary corrective actions.

Resource & Budget Management

  • Prepare the annual budget and ensure operations remain within specified limits.
  • Oversee the qualification and maintenance of microbiology equipment.

Role Accountabilities

  • Timely completion of tasks while ensuring regulatory compliance.
  • Continuous enhancement of laboratory standards and practices.
  • Effective response to audit observations with timely resolutions.

Educational Qualification

  • M.Sc. in Microbiology

Experience & Skills

  • Experience: 14–17 years of experience in microbiology with a strong focus on compliance and biologics manufacturing.
  • Skills:
    • Expertise in aseptic practices and biologics manufacturing/testing compliance.
    • Strong communication and team collaboration abilities.
    • Capability to identify improvement opportunities and implement necessary changes.
    • Assertiveness in task completion with personal integrity and a positive attitude.

Syngene Values

All employees are expected to demonstrate alignment with Syngene’s core values:

  • Excellence
  • Integrity
  • Professionalism

Equal Opportunity Employer

Syngene is committed to providing equal employment opportunities (EEO) regardless of age, gender, nationality, disability, or other protected characteristics. Reasonable accommodations will be provided for qualified individuals with disabilities.


For more information, visit Syngene's official website.