General Manager Operations
6 days ago
About the Company A Leading Pharma Group with Global Presence and approvals from EU-GMP, MHRA-UK, ANVISA Brazil, PICS Ukraine, WHO Geneva, INVIMA Colombia, USFDA*We have 3 facilities in North India and 1 R&D centre at Bengaluru ,1. Immacule Lifesciences- Manufacturing of Liquid and Lyophillized injections approved from MHRA, ANVISA, PICS Ukraine, USFDA2. Acme Formulation Pvt Ltd- Comprises of 2 blocks (General & Hormone) , manufacturing Tablets, Capsules approved by WHO Geneva,INVIMA,Peru,EU GMP3. Acme Generics LLP - Comprises of 2 blocks (General & Thyroxine) , manufacturing Tablets, Capsules approved by EU-GMP, TGA Responsibilities - Responsible for production related tasks including production planning and process control and troubleshooting for achieving the planned periodic schedules. - To ensure effective compliance of quality management system as per cGMP and international regulatory requirement in production and ancillary areas. - Responsible for implementation of systems, processes and procedures to facilitate smooth functioning of overall operations. - To ensure the execution of validated status of the injection facility. - To ensure effectiveness of all standard operating procedures, batch document, master documents of production and compliance to documents. - Assuring that the department is in compliance with cGMP/regulatory requirement. - Co-ordination for new product transfers and thereafter support for process validation. - Co-ordination with QA for self-inspection and compliance to the audit observation. - Responsible for improvement in product yield and productivity. - Proper utilization of man and machine and to ensure compliance for documents as per cGMP requirement. - To prepare and review capex, user requirement specification etc. - To prepare and review MIS report and other related documents of production department as per requirement. - To ensure that initial and continuing training of production persons has been performed as per schedule. - To confirm the training matrix, training reports of new and existing employees. - To ensure scheduled validation of the equipment, calibration of devices and maintenance of equipment. - Responsible for planning and implementation of preventative and predictive maintenance schedules. - Overseeing the recruitment, performance of subordinates, mentoring/motivating them to improve their contribution levels. - Responsible for man management and administrative functions and new Project management. - Responsible for implementation of system, processes and procedures to facilitate smooth functioning of overall operations enhance operational efficiency and cost optimization. - Market compliant investigation jointly with QA. - To comply and ensure the implementation of safety practices. - To report that entire daily schedules and executions to the management. - Responsible to self Inspection. - Review and approval of QMS elements and process documents through Ample logic and EDCS system. - Review and approval of RM, PM, consumable and other dispensing activities through ERP system. Qualifications - B.pharma/ M. Pharma Required Skills - Minimum 20 Years experience in Sterile Manufacturing and minimum 5 years in lead role.
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