Head of Pharmaceutical Operations

4 days ago

Nalagarh, India Immacule Lifesciences Full time

About the CompanyA 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, TGAResponsibilitiesResponsible 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. QualificationsB.Pharma/ M. Pharma Required SkillsMinimum 20 Years experience in Sterile Manufacturing and minimum 5 years in lead role.

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