Job Information
WuXi AppTec Senior Engineer, Manufacturing Compliance in 2108 Couvet, Switzerland
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.
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Job Locations CH-NE-2108 Couvet
Job ID 2024-12786