Assistant Manager

Responsible for handling of Process maintenance and engineering compliance activities (Deviation, SOPs,
change controls, CAPAs etc.)

Ensuring sustained cGMP and GDP compliance across technical, process and utility areas with
responsibility for equipment upkeep and lifecycle management.
Managing Computer System Validation (CSV) for PLC and SCADA systems in accordance with FDA
regulations and GLP, GMP, and GCP guidelines.

Providing technical oversight to ensure operational reliability, audit readiness, and adherence to
regulatory expectations in a highly regulated manufacturing environment.?

Expertise in operation and maintenance of OSD/Injectable manufacturing equipment and utility systems.

Hands-on experience in preventive and breakdown maintenance of OSD and injectable equipment with
strong root-cause problem-solving skills.
Capable of troubleshooting and resolving issues across electrical and instrumentation disciplines.?

Expertise in engineering compliance activities, including Change Control, Deviations, and CAPA
management using TrackWise.

Preparation, review, and implementation of SOPs and system upgrades across all stages of the equipment
life cycle.
Actively involved in qualification and validation of facilities and equipment to maintain the validated state

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