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Amneal Pharmaceuticals
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Assistant Manager, Manufacturing Injectables

Assistant Manager, Manufacturing Injectables

Amneal Pharmaceuticals

11 - 12 years

10 - 11 Lacs

ahmedabad

Posted:1 day ago| Platform:

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Skills Required

usfda rtu usage process engineering internal audit compliance sat assistant manager manufacturing operations project execution

Work Mode

Work from Office

Job Type

Full Time

Job Description

Greenfield Project Execution:

Assist in installation, commissioning, and qualification (IQ/OQ/PQ) of Optima PFS filling line, isolators, and associated equipment.

Participate in CSPE (Comprehensive Scientific Process Engineering) activities to ensure smooth and timely production startup

Support validation and engineering teams during FAT/SAT and process simulations.

Routine Operations:

Operate Optima PFS filling systems for ready-to-use (RTU) syringes in nested tubs, ensuring sterile and accurate filling

Perform de-bagging, Tyvek film removal, filling, closing, and secondary processing steps such as labeling and safety device assembly.

Monitor in-process controls (IPC) including fill volume, stopper height, and container integrity using systems like SIRM (Syringe Inspection and Reject Machine)

Ensure isolator integrity and aseptic conditions throughout the production cycle.

Compliance & Documentation:

Maintain accurate batch records, logbooks, and equipment usage documentation.

Adhere strictly to cGMP, Annex 1, and USFDA guidelines for sterile manufacturing.

Support internal audits and regulatory inspections with proper documentation and operational readiness.

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