Senior Engineer
vor 1 Tag
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Client:Gi Group SA
Location:Job Category:Manufacturing
Job Reference:6ef7c865c5ef
Job Views:5
Posted:21.01.2025
Expiry Date:07.03.2025
Job Description:Gi Life Sciences is looking for its partner in the Canton of Neuchâtel a:
SENIOR ENGINEER (MANUFACTURING COMPLIANCE)
Permanent Position
Your mission:
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.
Your profile:
- BS/MS in Engineering/Technical discipline or equivalent experience.
- 8 years' experience in pharmaceutical validation, packaging or related field.
- 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.
- Fluent in English and in French.
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