Senior Officer - Micro (Dadra)

Title: Senior Officer
- Micro Date: May 22, 2026 Location: Dadra
- Quality Control Company: Sun Pharmaceutical Industries Ltd 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
- Solid 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
- Robust 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/4lo2ux