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Process Specialist (Elanco)

Process Specialist (Elanco)
Primary Function
  1. Ensure production process strictly implemented during production, with basic yield and output reached.
  2. Ensure production orders are completed on time and in compliance with GMP/ HSE requirement.

Primary Accountabilities/Responsibilities
  1. Ensure that the production process is strictly implemented during production so as to ensure stable, on time and safe production. The product is qualified.
  2. Have continuous production process optimization, improvement and lean production. The production cost is reduced.
  3. Be responsible for the draft and update of production documents (main manufacturing procedure, DBPR, PCCR), timely production records check for product release purpose. Related validation documents if required.
  4. Plan for the production campaign changeover to ensure the production campaign change is in a stable state. Complete production campaign report on time.
  5. Be responsible for change control and deviation investigation according to GMP requirement.
  6. Take part in department’s new project introduction. Help department to implement department related projects.
  7. Train the production operators in production process, GMP, HSE and production technologies to ensure the operators to operate safely and in compliance with GMP/HSE requirement.
  8. Handle SAP affairs and maintain related documents in production department.
  • Bachelor degree or above, engineering or pharmaceutical background is preferred
  • Minimum CET 4,good ability in listening, speaking ,reading and writing
  • At least 2 years front line experience in production, equipment management experience in pharmaceutical industry is preferred.
  • Good knowledge in GMP and HSE