Head Microbiology

20+ years

Not Disclosed

India Remote

10 Feb. 11, 2025

Job Description

Job Type: Full Time Remote 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

Job Title: Head – Microbiology

Date: January 30, 2025
Department: Quality & Microbiology

JOB SUMMARY:

The Head of Microbiology is responsible for the oversight and monitoring of the Microbiology Laboratory at the site. This role ensures the microbiological quality of products manufactured and distributed to global markets while maintaining compliance with regulatory and safety standards.

KEY RESPONSIBILITIES:

Leadership & Oversight:

Provide leadership and direction to achieve all Quality and Microbiological goals.
Ensure consistency in Microbiology lab operations and drive continuous improvements.
Determine and allocate necessary resources (staff, instruments, training, lab space, etc.).
Train employees as a qualified trainer and ensure compliance with best practices.

Microbiological Testing & Release:

Organize and oversee microbiological testing and release of raw materials, finished products, commercial stability samples, exhibit stability samples, and miscellaneous samples.
Supervise microbiological testing and release of raw water, potable water, and purified water samples.

Environmental Monitoring:

Manage microbial environmental monitoring, including passive air, active air, compressed air, equipment surfaces, personnel monitoring, and drain points in manufacturing areas, warehouses, and the microbiology lab.
Ensure effective handling, maintenance, isolation, and identification of microbial cultures.

Compliance & Investigations:

Conduct and oversee investigations for out-of-specification (OOS) and out-of-trend (OOT) results, root cause analysis, corrective actions, and preventive actions (CAPA).
Manage change control processes and CAPA implementations.
Ensure adherence to cGMP/GLP and safety standards in the microbiology lab.
Conduct internal audits as per site-specific procedures.
Participate in external and regulatory inspections of Microbiology operations at the site.

Documentation & Reporting:

Review logbooks, instrument calibration records, periodic performance records, data summary reports, and certificates of analysis for accuracy and completeness.
Prepare trend and annual summary reports on raw water, potable water, purified water, microbial environmental monitoring, and microbial isolates.
Ensure all product compliance activities are performed effectively in the Quality Control Microbiology Laboratory.

Additional Responsibilities:

Perform all duties in alignment with corporate values: Pride, Accountability, Integrity, and Diligence.
Execute any additional responsibilities as assigned by the Quality Head.

JOB REQUIREMENTS:

Educational Qualification:

Minimum: M.Sc. in Microbiology

Experience:

Minimum: 20+ years of experience in microbiology, preferably in a pharmaceutical manufacturing environment.

Skills & Certifications:

Strong expertise in microbiological testing and quality control.
Knowledge of regulatory requirements, cGMP, GLP, and safety compliance.
Experience in laboratory management, investigations, and audits.
Leadership and team development capabilities.

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