Assistant General Manager, Manufacturing Injectables

To review, develop and introduce systems, practices and cultural changes that enable the production
department to meet business demands within agreed time frames and expected GXP standards. To prepare production planning on monthly basis as per the production requirement and availability of materials. To discuss production plans with subordinates and scheduling weekly plans / allocation of weekly shift schedule. Daily work allocation to supervisors & workmen. Achieving set targets of daily/weekly /monthly manufacturing/packaging plan. To interact with Warehouse/QC/QA for the material availability / release and schedule the production plan. To propose and implement innovative ideas towards improvements in process efficiency, productivity, delivery, quality, yield, safety resulting in successful operations. To manage the troubleshooting activity, ensuring identification of appropriate corrective measures and driving structured implementation of these measures through cross-functional teams. To perform Gap analysis of defined procedures in Batch Manufacturing Record / Batch Packing Record / Standard Operating Procedure / Protocol and initiation of corrective actions. To impart continuous training to the workforce for enhancing their productivity & operational efficiencies through knowledge enhancement / skill building. To ensure effective execution of new product introduction and technology transfer of any product to the Site. To prepare & review of SOPs related to production department. To review of documents like log books, BMR, BPR for error free online documentation and timely submission to QA. To co-ordinate with all concerned departments for providing cost efficient services and achieving excellence. Planning and execution of media fill validation along with Validation Team. To ensure timely execution of equipment qualification along with Validation Team. To review the annual validation plan, preventive maintece plan and calibration plan. Ensure timely initiation and closure of QMS documents of production department like change control, deviations, CAPA and Risk Assessments with the stipulated timeframes. To involve and implement in self-inspection of the system and use the findings from such audits for overall improvement of facility, systems and documentation process. Compliance to the regulatory authorities with respect to the investigations.