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).
Valuable documentation, troubleshooting, and team-handling skills.
Ability to work in shift operations.

📌 Chemist/officer/ Sr Officer Navsari
🏢 Job Excel
📍 Navsari