Manufacturing Compliance Expert

vor 3 Wochen


ValdeTravers District, Schweiz WuXi AppTec Vollzeit
Senior Engineer, Manufacturing Compliance

We are seeking a highly skilled Senior Engineer, Manufacturing Compliance to join our team at WuXi AppTec. This key role will be responsible for ensuring the highest standards of quality and compliance in our manufacturing operations.

Key Responsibilities
  • Develop and lead updates of Good Manufacturing Practice (GMP) documents related to Bulk and/or Packaging Operations.
  • Initiate and own deviations related to Bulk and/or Packaging Operations, and lead investigation tasks as required.
  • Support the Head of Bulk and/or Packaging Operations in monitoring quality and performance metrics.
  • Act as a referee for the operational team for GMP systems, documentation, and training.
  • Act as deputy to the Head of Bulk and/or Packaging Operations.
Requirements
  • Bachelor's or Master's degree in Engineering or a related technical discipline.
  • At least 8 years of experience in pharmaceutical validation, packaging, or a related field.
Desired Skills and Qualifications
  • Sound knowledge of current international regulatory regulations, cGxP requirements, and best practices.
  • Experience in Health Authority inspections, including preparation, process, presentations, and responses.
  • Knowledge of pharmaceutical facilities, manufacturing, and laboratory systems and processes.
  • Strong analytical, problem-solving, and communication skills.
  • Ability to work effectively across functional areas and levels to achieve results.
  • Fluent in English and French.


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