Job Description
Production Operations:
Manage day-to-day sterile injectable manufacturing activities including
SVP/LVP manufacturing
Compounding and filtration
Aseptic filling & sealing
Vial / Ophthalmic / PFS filling operations
Lyophilizer loading/unloading (if applicable)
Ensure adherence to batch manufacturing records (BMR/BPR) and production schedules.
Coordinate with warehouse for timely availability of raw and packing materials.
Aseptic Area & Cleanroom Management
Ensure compliance with aseptic practices and gowning procedures.
Monitor cleanroom discipline and environmental control practices.
Ensure cleaning, sanitization, and line clearance activities are performed effectively.
Documentation & Compliance
Review and ensure proper completion of
eBMR/eBPR
eLogbooks
Equipment usage records
Area cleaning records
Handle deviations, change controls, incidents, and CAPA in coordination with QA.
Ensure compliance with cGMP, USFDA & EU-GM...
Manage day-to-day sterile injectable manufacturing activities including
SVP/LVP manufacturing
Compounding and filtration
Aseptic filling & sealing
Vial / Ophthalmic / PFS filling operations
Lyophilizer loading/unloading (if applicable)
Ensure adherence to batch manufacturing records (BMR/BPR) and production schedules.
Coordinate with warehouse for timely availability of raw and packing materials.
Aseptic Area & Cleanroom Management
Ensure compliance with aseptic practices and gowning procedures.
Monitor cleanroom discipline and environmental control practices.
Ensure cleaning, sanitization, and line clearance activities are performed effectively.
Documentation & Compliance
Review and ensure proper completion of
eBMR/eBPR
eLogbooks
Equipment usage records
Area cleaning records
Handle deviations, change controls, incidents, and CAPA in coordination with QA.
Ensure compliance with cGMP, USFDA & EU-GM...
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