13 Sep
|
Sun Pharmaceutical Industries
|
Dadra and Nagar Haveli and Daman and Diu
13 Sep
Sun Pharmaceutical Industries
Dadra and Nagar Haveli and Daman and Diu
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 settings 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 microb
📌 Senior Officer Dadra And Nagar Haveli And Daman And Diu
🏢 Sun Pharmaceutical Industries
📍 Dadra and Nagar Haveli and Daman and Diu