Head of Production

Experience Required: 15 to 20 years Functional Competencies: Hard-core Exposure to Injectable and Solid Dose Manufacturing, Planning & Operation Management in Regulatory Work Environment. Will oversee all daily operations of the manufacturing and packaging ensuring policies and procedures are followed. Increase production, assets capacity and flexibility while eliminating unnecessary costs and maintaining current quality standards. Proven Regulatory exposure in leadership role tor US-FDA, MHRA, Anvisa. PICs etc. Knowledge of Production Optimization, Resource Management and fair understanding on quality and regulatory domain. Adequate knowledge of product, process and equipment. Responsible to implement CAPAs committed to Regulatory agencies. Responsible for validation of process, cleaning and equipment. Develop systems and processes that track and optimize productivity and standards, metrics and performance targets to ensure effective return on assets. Ensuring production personnel are trained for their job To prepare and establish production procedures as per regulatory requirements To ensure maintenance and calibration activities for facility, equipment and instruments. To maintain requisite spares for un-interrupted production. To establish hold time period for in-process product and cleaned/un-cleaned equipment To ensure product is manufactured as per instructions and records are filled contemporaneously. Ensure procedures are in place for operation and cleaning of equipment To ensure cleaning of facility and equipment. To ensure products are stored as per storage conditions and records of environment monitoring are maintained To ensure cleanliness in change rooms and toilet facility for production personnel

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