Parenteral Block Head

Title:

Job Grade:

Educational Qualification:

Location:

Experience:

• Knowledge of

  parenteral manufacturing operations

• Understanding regulatory guidelines
• Leadership & Team Management Skills
• Problem Solving & Decision-Making
• Proficiency in handling production documentation & compliance

• Min. 15 years of experience working in sterile manufacturing plant or Block In-charge experience

Position Summary

• Responsible for

  plant operations

  from material procurement to product dispatch along with operational activities, manufacturing actions, lean management, training, regulatory compliance, cross functional coordination, new product projects, new CAPEX projects, safety and administrations.
• Monitoring and control of the manufacturing environment, plant hygiene, compliance to requirement of current Good Manufacturing Practice, EHS, local and international regulatory norms.
• To coordinate for external/regulatory GMP audits at plant and to ensure timely compliance of audit observations.
• Optimum utilization of man, material and machinery of pharmaceutical products and assuring adequate resource arability with focus of safety and quality first.
• Ensuring lean management, operation excellence, GEMBA, yield improvement and waste reduction etc. with action plan and its implementation.
• Responsible to review and approve the qualification related documents as URS, DE, FAT, SAT, IQ, OQ, PQ etc.
• To coordinate with FDD/PDD (R&D)/ MSTG for execution of trial/ exhibit/ process validation batches and trouble shooting.
• Implementation of effective control on budgetary provisions and cost reduction measures.
• Supervision of proper production planning, plan execution as per schedule and ensure that products are produced and stored according to appropriate safety, cGMP requirement.
• Ensuring protection of the product from contamination and maintain quality as required.
• Participate in management reviews of process performance, product quality and of the quality management system and advocating continual improvement.