Packaging Group Lead - Day Shift at Amneal India
Piscataway, New Jersey, United States -
Full Time


Start Date

Immediate

Expiry Date

30 Jul, 26

Salary

35.0

Posted On

01 May, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Manufacturing process leadership, HMI control systems, Batch record management, Data entry, Label reconciliation, Vision system report verification, Equipment calibration, Equipment setup, Equipment cleaning, cGMP standards, ROSS transactions, Personnel scheduling, SOP compliance, CAPA adherence, Cross-contamination prevention

Industry

Pharmaceutical Manufacturing

Description
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.   This role follows a 12-hour rotating schedule, working from 6:00 AM to 6:30 PM 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).    * 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: * Always wear appropriate safety and protective gear and comply with the designated dress code requirements. * Others duties as assigned. Amneal is an Equal Opportunity Employer that does not discriminate on the basis of sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, liability for service in the U.S. Armed Forces or any other characteristic protected by applicable federal, state, or local laws.
Responsibilities
The Group Leader oversees the manufacturing process, ensuring precise batch production and operation of advanced HMI-controlled systems. They are responsible for maintaining strict compliance with cGMP standards, managing documentation, and coordinating personnel to ensure efficient operations.
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