Packaging Team Lead

Lead Packaging Technician Glenmark is a leading player in the discovery of new molecules both NCEs (new chemical entity) and NBEs (new biological entity) with eight molecules in various stages of clinical development. The company has a significant presence in branded generics markets across emerging economies including India. Its subsidiary, Glenmark Generics Limited has a fast growing and robust US generics business. The subsidiary also markets APIs to regulated and semi-regulated countries. Glenmark employs nearly 16,000 people in over 80 countries and with its twelve manufacturing facilities in four countries, five R&D centers and Front-ends in US, EU, India, Brazil and other markets worldwide, Glenmark is well placed on the road of growth and is exceedingly well prepared to take the completion head-on. A Lead Packaging Technician is responsible for the inspection and secondary packaging of vials and syringes for commercial distribution in accordance with the schedule put forward by production leadership. The position is considered a "working lead" position meaning that personnel in this role will organize team members to complete daily operation requirements as well operate manufacturing processing equipment serving as SME, by following standard operating procedures and batch records in accordance with FDA current Good Manufacturing Practices. In addition, personnel in this position will support the production operation by handling visual inspection, CCIT, labeling, cartoning, and serialization of filled syringes and vials. Personnel in this position will serve as SOP and BPR subject matter experts reviewing, closing out, and revising these documents as deemed required by production leadership. Key Responsibilities: Troubleshoots a majority of basic machine issues and reaches out for maintenance support when needed in order to meet production timelines. Serves as setup mechanic for all area specific filling equipment. Identifies and implements operational optimizations of the equipment via machine recipe parameter adjustment, including timers, counters and cams. Review and correction of area specific executed batch records and log books to meet timely closure of the documents. Supports and/or leads daily meetings to communicate day's activities and production needs Communicates effectively with area leadership and cross-functional departments including maintenance, QC microbiology, QC chemistry and IPQA to align production needs and ensure timely completion of production schedule. Identifies deviations in real time and assists with write up of the issue and investigation in Master Control, taking guidance from IPQA, QEM and production leadership. Possesses competitive, detailed oriented production mentality and is not satisfied by anything less than perfection. Thinks creatively within the bounds of cGMP framework to overcome challenges and brings viable solutions to the table. Provides training to other operators. Follows written procedures. Clearly and accurately documents activities. Performs basic math calculations. Submits in-process samples to responsible departments. Performs cleaning of rooms, tools and equipment. Performs specific visual inspections based on clearly outlined checks and specifications for the finished product. Responsible to ensure that the product meets specification Read, understand and review SOP's and Protocols as required.