General Manager Operations

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.