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Chemist/Officer/ Sr. Officer - Production (Injectable)

Job Description - Chemist/Officer/ Sr. Officer - Production (Injectable)

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
  • Strong 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.



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