Head of Production

3 weeks ago

Kozhikode, Kerala, India Talent Sutra Full time

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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