12 Sep
|
Sun Pharmaceutical Industries
|
Dadra and Nagar Haveli and Daman and Diu
12 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 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 microb
📌 Senior Officer (Dadra and Nagar Haveli and Daman and Diu)
🏢 Sun Pharmaceutical Industries
📍 Dadra and Nagar Haveli and Daman and Diu