Title:  Executive - Micro

Position Overview

The Executive Microbiologist is responsible for execution, review, and compliance of microbiological testing activities for raw materials, in‑process samples, finished products, utilities, cleanrooms, and sterile/non‑sterile environments in line with USFDA, cGMP, and global regulatory requirements. The role ensures microbiological control, regulatory compliance, and audit readiness for OSD manufacturing operations.

Key Responsibilities

Routine Microbiological Testing

• Perform and review microbiological analysis of raw materials, finished products, stability samples, and packing materials (as applicable).
• Handle bioburden testing, microbial limit tests (MLT), pathogen testing, and sterility‑related support activities (where applicable).
• Conduct water system testing including Purified Water and Drinking Water (chemical & microbiological support).

Environmental Monitoring & Utilities

• Execute and trend Environmental Monitoring (EM) of production areas (OSD): viable and non‑viable monitoring.
• Perform sampling and analysis of compressed air, gases, surface, personnel, and utilities.
• Review EM data, identify trends, and initiate deviations/CAPAs where required.

Media & Culture Handling

• Preparation, sterilization, dilution, and qualification of culture media.
• Perform media growth promotion tests (GPT).
• Proper handling, storage, and disposal of microbial cultures as per biosafety norms.

Documentation & GMP Compliance

• Prepare, review, and maintain documentation such as:
  • Test reports
  • Logbooks
  • SOPs
  • Deviations, OOS, OOT, and CAPAs
• Ensure compliance with cGMP, ALCOA+, data integrity, and laboratory SOPs.
• Maintain laboratory housekeeping, calibration, and cleanliness of microbiology lab.

Audit & Regulatory Support

• Support USFDA, MHRA, WHO, and internal audits.
• Prepare and present microbiology data during inspections.
• Assist in investigation and response to audit observations related to microbiology and contamination control.

Validation & Qualification Support

• Participate in cleanroom qualification and requalification.
• Support validation activities for water systems, disinfectants, cleaning procedures, and microbiology test methods.
• Execute method verification/validation activities as required.

Qualifications & Experience

Education

• M.Sc. in Microbiology / Applied Microbiology / Biotechnology or equivalent

Experience

• 5–8 years of hands‑on experience in QC Microbiology within a USFDA‑approved OSD manufacturing facility
• Strong exposure to regulatory audits and GMP practices

Technical & Regulatory Knowledge

• In‑depth knowledge of:
  • USFDA, cGMP, ICH, WHO guidelines
  • Microbial limits testing & EM programs
  • Data Integrity & GDP
• Familiar with pharmacopeias: USP, EP, IP
• Good understanding of contamination control strategies

Key Competencies

• Strong analytical and documentation skills
• Ability to handle audit queries confidently
• Team coordination and communication skills
• Detail‑oriented with a compliance mindset

Preferred Skills

• Experience handling USFDA inspections
• Exposure to data integrity remediation
• Leadership capability to guide junior microbiologists