Executive

Production Operations

• Monitor cleaning of area drains and update related documentation.
• Update room and equipment status labels as per procedure.
• Verify availability and readiness of materials and equipment required for batch processing.
• Prepare production areas and equipment prior to batch activities.
• Execute and monitor batch processes, ensuring compliance with GMP standards.
• Handle sampling and labeling of in-process and final product samples.
• Report incidents and abnormalities to the Shift In-Charge promptly.
• Assist in column packing, unpacking, and evaluation activities.

Chromatography and Resin Handling

• Perform monitoring and maintenance of chromatography columns and resins throughout the process lifecycle.

Documentation Management

• Review new and revised SOPs and protocols for practical feasibility.
• Update logbooks, batch manufacturing records (BMRs), and online annexures accurately and in a timely manner.

Equipment Operation

• Operate key production equipment including but not limited to:
• AKTA Process and AKTA Pilot Purification Systems
• TFF Systems
• Peristaltic Pumps
• LAFU and Filter Integrity Tester
• pH Meter, Conductivity Meter
• Mixing Systems and Heat Exchangers
• Walk-In Cold Rooms and Freezer Rooms

Training and Compliance

• Attend training sessions on GMP, SOPs, and other regulatory procedures as per schedule.

Quality Management Systems (QMS)

• Initiate breakdown requests and coordinate maintenance.
• Initiate and support Change Request Notes (CRNs), incident reports, investigations, and CAPAs in alignment with QMS standards.