
Head of Production
1 week ago
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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