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.