Head of Manufacturing

• Prepare and Monitor Operational Plan for Optimum utilization of Resources i.e. Material, Labour & Overheads
• Ensure that products are manufactured under conditions that meet Abbott Policies, EHS Standards, and Regulatory and cGMP requirements.
• Ensure compliance with labor laws, security standing orders & code of Business conduct.
• Ensure provision of the necessary resources (area, equipment, workforce, etc.) to produce products of the required quality.
• Ensure that required initial and continuing training of production personnel including GMP training is carried out and adapted according to need.
• Provide strategic direction in Mfg. technology and equipment. Ensure that maintenance of premises and equipment, calibrations, and Process Validation are performed and recorded.
• Coordinate with Quality regarding QA Audits, CAPA, Complaints, ERs, Market Returns, and Trend Analysis Reports, etc.
• Coordinate with QA, Regulatory, Technical Centre, Engineering, and Supply Chain in the resolution of quality problems, disposition of nonconforming issues, and ensure uninterrupted product deliveries to Commercial.
• Prepare Plant annual budget in consultation with Finance and get it approved by Management.
• Take into account all demands, including forecasts, contracts, customer orders, samples, special prototypes, spares, interplant, etc in creating a Master Schedule that directs and drives all manufacturing, purchasing, and manufacturing-related engineering activities.
• Monitor KPIs and perform Root Cause Analysis where applicable.
• Review and approve technical documents including SOPs, Manufacturing and Finishing Directions including in-process controls, Shop Orders, Validation documents, Change requests, CAPA and ERs, etc.
• Ensure that the production records are re-evaluated and signed by a designated person before they are made available to the Quality Assurance department.
• Review new product dossiers and Manufacturing input for preparation of product registration / re-registration and their submission to the Regulatory Department.
• Review batch variance/yield reports with production managers and take appropriate steps for improvement.
• Expose, prioritize, and stimulate the reduction or elimination of non-value-added activities.
• Ensure employee development, Goal Setting, Performance Assessment, and succession planning within the department.
• Any other task assigned by Director Operations.

• B.Pharm/Pharm.D
• 10 years of working experience in Manufacturing and Finishing operations
• Knowledge of Drug Rules, cGMP requirements, and Quality Standards
• Understanding of Supply Chain Management of Multi-National Companies
• Awareness of Operational Finance and Capital Budgeting
• Understanding of Business Excellence (CI) and New Product Development activities

• Good communication and Interpersonal skills
• Proven Leadership qualities
• Ability to thrive in a fast-paced environment

Abbott