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Senior Engineer, Manufacturing Compliance

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10/06/2024 100% Permanent position
STA Pharmaceutical Switzerland SA
Senior Engineer, Manufacturing Compliance
Overview

The Senior 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. He/she supports the Head of Bulk and/ or Packaging Operations in monitoring quality and performance metrics and acts as a referee for the operational team for GMP systems, documentation and training. He/she acts as deputy to the Head of Bulk and/or Packaging.

Qualifications

Experience / Education

  • BS/MS in Engineering/Technical discipline or equivalent experience
  • 8 years' experience in pharmaceutical validation, packaging or related field

Knowledge / Skills / Abilities:

  • 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.

Place of work

Rue du Pré-Jorat 18

2108 Couvet


About the company

Couvet / Neuchâtel

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