Manufacturing Compliance Senior Expert

Vor 2 Tagen


ValdeTravers District, Schweiz WuXi AppTec Vollzeit

Job Summary

The Senior Compliance Engineer for Manufacturing Compliance will be responsible for authoring, owning, and leading updates of GMP documents related to Bulk and/or Packaging Operations. This role will also initiate and own deviations related to Bulk and/or Packaging Operations and lead investigation tasks as required. Additionally, the Senior Compliance Engineer will support the Head of Bulk and/or Packaging Operations in monitoring quality and performance metrics and act as a referee for the operational team for GMP systems, documentation, and training. Furthermore, the Senior Compliance Engineer will act as deputy to the Head of Bulk and/or Packaging.

Key Responsibilities

  • Author, own, and lead updates of GMP documents related to Bulk and/or Packaging Operations.
  • Initiate and own deviations related to Bulk and/or Packaging Operations.
  • 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.

Requirements

  • BS/MS in Engineering/Technical discipline or equivalent experience.
  • 8 years' experience in pharmaceutical validation, packaging, or related field.
  • Sound knowledge of current international regulatory regulations, cGxP requirements, and best practices, including 21 CFR part 11, 210, and 211, Annex 11, EU-GMP guidelines, and GAMP.
  • Experienced in Health Authority inspections (preparation, process, presentations, responses drafting, etc).
  • Knowledge of pharmaceutical facilities, manufacturing, and laboratory systems and processes.
  • Well-developed ability to constructively work across functional areas and levels to achieve results.
  • Strong verbal and written communication skills.
  • Strong analytical, problem-solving, influential, and deductive skills.
  • Capability to work with short deadlines and simultaneous activities.
  • Excellent organizational and project management skills.
  • Successful experience in direct people management.
  • Fluent in English and in French.


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