Senior Officer - Micro (Dadra)

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
- Valuable 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 Apply on Kit Job: kitjob.in/job/4lpmiw