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Description:

The Group Leader is responsible for leading the manufacturing process of batches. In addition, the Group Leader will perform and demonstrate the actual methods and procedures to produce the products utilizing state of the art processing systems. These systems include sophisticated recipe-controlled human machine interface (HMI) control systems.

Essential Functions:

+ Verify all product and packaging/manufacturing components prior to the start of operations and entry into the packaging room. Check and confirm the product, ousters, and labels against the product specifications outlined in the batch record, work order, and packaging record. Ensure accurate data entry in all logbooks and confirm the completion of documentation for each batch

+ Initiate the batch record according to the production schedule and verify the staging status of the upcoming batch for each line. Print and inspect shipper case labels to ensure accuracy. Ensure 100% label reconciliation, verify results with the vision system report, and submit all reviewed documentation to Quality Assurance in a timely manner

+ Adhere to the manufacturing schedule based on the shipping forecast. Ensure proper status identification of manufacturing components in the manufacturing/packaging rooms throughout the process. Responsible for the disposal of rejected material and packaging components in accordance with established procedures

+ Verify the calibration status of all equipment before use. Perform equipment setup, operation, and cleaning in compliance with cGMP standards. Promptly complete all ROSS transactions and strategically schedule personnel to ensure an efficient process across the manufacturing rooms.

+ Must adhere to Amneal Packaging CAPAs and Standard Operating Procedures (SOPs). Always wear appropriate safety and protective gear and comply with the designated dress code requirements.

+ Maintain focus throughout the manufacturing/packaging process to prevent mix-ups and cross-contamination. Ensure all rooms remain clean, organized, and compliant at all times.

Additional Responsibilities:

+ Others duties as assigned.