Specialist, Manufacturing Compliance

vor 1 Woche


ValdeTravers District, Schweiz WuXi AppTec Vollzeit

The Engineer, Manufacturing Compliance authors, owns and leads updates of GMP documents related to Bulk and/or Packaging Operations.
He/she initiates and owns deviations related to Bulk and/or Packaging Operations and leads investigation tasks as required.

Responsibilities:

  • Support deviations and participate in floor investigations.
  • Collaborate with QA and Packaging or Bulk Operations for thorough assessments and investigations.
  • Ensure implementation of assigned CAPAs.
  • Author and review manufacturing (bulk/packaging) documents.
  • Lead risk assessments and cross-functional teams for risk management.
  • Review and approve batch records and associated parameters in the electronic system.
  • Conduct complaint investigations linked to Manufacturing.
  • Initiate, own, and follow up on change controls related to manufacturing.
  • Contribute to continuous improvement and propose solutions.
  • Participate in projects and initiatives as directed.

Requirements:

  • BS/MS in Engineering/Technical discipline or equivalent experience.
  • 8 years' experience in pharmaceutical validation, packaging, or related field.
  • Sound knowledge of international regulatory regulations, GxP requirements, and best practices.
  • Experienced in Health Authority inspections.
  • Knowledge of pharmaceutical facilities, manufacturing, and laboratory systems.
  • Strong communication, analytical, problem-solving, and project management skills.
  • Experience in direct people management.
  • Fluent in French and English.


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