Instagram
youtube
Facebook

Head Microbiology

20+ years
Not Disclosed
10 Jan. 31, 2025
Job Description
Job Type: Full Time Education: None 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

📌 Head of Microbiology | [Company Name] | Location: [Insert Location]

📍 Location: [Insert Location]
💼 Company: [Insert Company Name]
🕒 Experience: 20+ years in microbiology and quality control

Position Summary

The Head of Microbiology will lead and oversee the Microbiology Laboratory at the site, ensuring the microbiological quality of products manufactured and distributed globally. The position involves ensuring compliance with regulatory standards, overseeing microbiological testing, environmental monitoring, and continuous improvement of lab operations, all while adhering to cGMP, GLP, and safety standards.

Key Responsibilities

Leadership & Direction: Provide leadership to meet microbiological goals and ensure the quality of microbiological testing and release for various samples, including raw materials, finished products, stability, and more.
Microbiological Testing: Organize and oversee testing for raw/potable/purified water and various microbial samples in the microbiology lab.
Environmental Monitoring: Ensure proper microbial environmental monitoring, including air, equipment surfaces, personnel, and drain points in manufacturing and laboratory environments.
Culture Maintenance & Investigation: Maintain microbial cultures, ensure accurate isolation and identification, and investigate out-of-specification results and trends, implementing corrective actions.
Compliance & Quality Assurance: Ensure compliance with cGMP/GLP standards, manage change control and CAPA, and prepare trend and annual summary reports.
Training & Development: Conduct training as a qualified trainer, ensuring staff are adequately prepared for laboratory tasks and safety standards.
Audit & Documentation: Perform internal audits as per site-specific procedures, review logs, instrument calibration records, and ensure documentation accuracy.
Continuous Improvement: Drive continuous improvement in lab operations, ensuring consistency and quality of microbiology functions at the site.
Regulatory Inspections: Participate in external and regulatory inspections of microbiology operations to ensure compliance and preparedness for audits.

Skills and Attributes

💡 Leadership: Strong leadership and management skills to guide and mentor microbiology staff.
💡 Analytical: Expertise in microbial testing, environmental monitoring, and root cause analysis.
💡 Compliance Knowledge: In-depth knowledge of cGMP/GLP and regulatory standards for microbiological operations.
💡 Training & Development: Ability to train, mentor, and develop team members to maintain high operational standards.
💡 Problem Solving: Excellent ability to manage investigations, corrective actions, and compliance-related issues.

Qualifications and Experience

🎓 Education:

  • M.Sc. in Microbiology
    💼 Experience:
  • Minimum 20+ years of experience in microbiology, with a focus on quality control, testing, and environmental monitoring in a regulated pharmaceutical environment.
  • Proven leadership experience managing microbiology teams and ensuring compliance with industry standards.

Work Conditions

  • Full-time position
  • Location: [Insert Location]

📩 Apply Now