Senior Engineer, Manufacturing Compliance
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.
Lieu de travail
Rue du Pré-Jorat 18
2108 Couvet
À propos de l'entreprise
Couvet / Neuchâtel
