Production Floor/Packaging Line Leader (2nd Shift)

With 64 manufacturing sites in 26 countries, our aspiration is to become the top manufacturer of innovative and generic medicines in the industry<br><br>Purpose:<br>Responsible for releasing and controlling production lines, ensuring production line staff are operating the lines and handling the material/equipment according to product specifications, reviewing batch paperwork, performing line clearances, setting up and monitoring all batches<br><br>Major Accountabilities<br>• • Provides direction/line assignments to packaging personnel to meet schedule adherence.<br>• Starts up production lines at the beginning of the shift and at the start of batches to release lines.<br>• Monitors lines including correct weights, lot number, expiration date and scans in drums of product.<br>• Calculates and documents in Filling Instructions tare weights for each packaging component number.<br>• Reviews batch paperwork for accuracy and issues to the batch records clerk. <br>• Checks and prepares paperwork for upcoming batches.<br>• Sets up and monitors cleaning and filling Validation batches according to protocols.<br>• Accepts and controls labels for individual orders. Counts and verifies labeling, packaging components and finished product against pick list, material list report, and palletizing pattern. <br>• Processes paperwork for Labeling Returns and brings returns to the Label Room or the Batch Clerks Office. <br>• Verifies correctness of components and product per the Filling Instructions.<br>• Reconcile, Track and Trace quantity and prints pallet tickets <br>• Enters counts electronically and documents line status in log books.<br>• Performs line clearances, counts and documents returns to stock. <br>• Performs SAP transactions such as Return to Stock (RTS) or paper transfer using scanning guns. <br>• Sets up electronic marquees indicating the product information for production lines.<br>• May calibrate scales/checkweighers on a daily basis or when moved to new locations on the production floor.<br>• Checks all cleaned parts on the production line.<br>• Provides feedback on operator performance.<br>• Interacts with production management, mechanics, and Quality Assurance.<br>• Participates in training of new employees.<br>• Contributes to the team by supporting other lines and roles as necessary to maintain operational efficiency.<br>• Maintain effective communication between shifts.<br>• Maintains compliance with SOPs, good documentation practices (GDP), training requirements, Company and safety policies and current Good Manufacturing Practices (cGMPs).<br>• Adheres to all applicable procedures, cGMP’s, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA, EMEA, ANVISA, HS&E, etc.). <br>• Ensures all work is performed in a safe, effective manner, and in compliance with the appropriate industry and regulatory (FDA, DEA, OSHA) standards, and Departmental, Plant, and Corporate quality and safety Behaviors.<br>Note: This position may require the labeling, packaging or movement of hazardous (flammable, corrosive, toxic, etc.) waste within the facility. If so, this employee would be trained under OSHA’s HAZWOPER standard, 29 CFR 1910.120 as an 8-Hour first responder, 24-Hour incident commander, or a 40-Hour incident commander.<br><br>In lieu of HAZWOPER training, the employee will receive training on the requirements of the Resource Conservation and Recovery Act pursuant to 40 CFR 265.16.<br><br>All employees that have received the above-mentioned training upon hire will receive annual refresher training that covers the OSHA HAZWOPER standard and the requirements of RCRA.<br><br>[#video#https://www.youtube.com/watch?v=ggbnzRY9z8w{#400,300#}#/video#]