Key Responsibilities:
- Execute and supervise injectable production operations including compounding, filtration, aseptic filling, sealing, sterilization, and visual inspection.
- Operate and manage SVP & LVP manufacturing lines, including vial, ampoule, PFS, and bottle filling systems.
- Handle and supervise lyophilization processes, including loading/unloading, cycle monitoring, and documentation.
- Ensure strict adherence to aseptic practices, cleanroom behavior, and cGMP guidelines.
- Review, prepare, and maintain Batch Manufacturing Records (BMRs) and production-related documentation.
- Perform line clearance, in-process checks, and coordinate with QA for batch release activities.
- Monitor critical process parameters, yields, and ensure compliance with approved SOPs.
- Investigate deviations, incidents, and breakdowns, perform root cause analysis, and implement CAPA in coordination with QA.
- Train and guide production staff on GMP, aseptic techniques, SOPs,



and safety practices.
- Coordinate with QA, QC, Engineering, and Warehouse for smooth and compliant operations.
- Ensure data integrity (ALCOA+), housekeeping, and adherence to EHS guidelines.

Requirements
Key Skills & Competencies:

Experience: 2 to 5 Years

Qualification: B. Pharm / M. Sc / B. Sc

Department: Production – Injectable Manufacturing

Industry: Pharmaceutical
- Solid hands-on experience in Injectable production (SVP/LVP).
- In-depth knowledge of aseptic manufacturing and sterile area operations.
- Practical exposure to lyophilization equipment and processes.
- Sound understanding of regulatory requirements (USFDA/EU-GMP/WHO-GMP).
- Good documentation, troubleshooting, and team-handling skills.
- Ability to work in shift operations.

📌 Chemist/Officer/ Sr. Officer (Navsari)
🏢 Job Excel
📍 Navsari