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Head Microbiology

20+ years
Not Disclosed
10 Dec. 4, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Position Title: Head – Microbiology
Department: Quality and Microbiology
Location: [Company Name]

Job Summary

The Head of Microbiology is responsible for overseeing and monitoring the Microbiology Laboratory at the site, ensuring the microbiological quality of products manufactured and distributed to global markets. This leadership role ensures compliance with all quality and microbiological standards and drives continuous improvement in laboratory operations.

Essential Job Functions

  1. Leadership & Direction

    • Lead and direct the achievement of all quality and microbiological goals for the site.
    • Ensure efficient operation of the microbiology laboratory to meet quality standards.
  2. Microbiological Testing & Release

    • Oversee the testing and release of various samples, including raw materials, finished products, stability samples (commercial and exhibit), and miscellaneous samples.
    • Organize the testing and release of raw, potable, and purified water samples.
  3. Environmental Monitoring

    • Manage the microbial environmental monitoring program, including air, equipment surfaces, personnel monitoring, and drain points in manufacturing blocks, warehouses, and microbiology labs.
  4. Microbial Cultures & Identification

    • Oversee the handling and maintenance of microbial cultures, ensuring proper isolation and identification of microbial isolates from various sources.
  5. Investigation & Root Cause Analysis

    • Participate in the investigation of out-of-specification results, trends, and perform root cause analysis and corrective actions to ensure compliance with quality requirements.
    • Manage change control and CAPA processes.
  6. Regulatory Inspections & Compliance

    • Participate in external and regulatory inspections of microbiology operations at the site.
    • Ensure compliance with cGMP, GLP, and safety standards in microbiology laboratory operations.
  7. Reporting & Documentation

    • Prepare trend and annual summary reports for raw/potable/purified water, microbial environmental monitoring, and microbial isolates.
    • Review log books, calibration records, performance records, data summaries, and certificates of analysis for accuracy.
  8. Training & Resource Management

    • Impart training to employees as a qualified trainer.
    • Ensure availability of resources (staff, instruments, lab space) for microbiology functions at the site.
  9. Continuous Improvement & Audit

    • Drive continuous improvements in laboratory performance and ensure consistency in operations.
    • Conduct internal audits per site-specific procedures.
  10. Corporate Values & Compliance

  • Perform all tasks in alignment with the company’s core values of Pride, Accountability, Integrity, and Diligence.
  • Ensure all activities comply with regulatory, safety, and corporate standards.

Minimum Education & Experience Requirements

  • Education: Minimum M.Sc. in Microbiology
  • Experience: Minimum 20+ years in microbiology, with a focus on leadership in quality and microbiological operations in the pharmaceutical industry.