Aktuelle Jobs im Zusammenhang mit Manufacturing Compliance Senior Expert - ValdeTravers District - WuXi AppTec
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Manufacturing Compliance Senior Expert
vor 1 Monat
Job Summary
The Senior Compliance Engineer for Manufacturing Compliance will be responsible for authoring, owning, and leading updates of GMP documents related to Bulk and/or Packaging Operations. This role will also initiate and own deviations related to Bulk and/or Packaging Operations and lead investigation tasks as required. Additionally, the Senior Compliance Engineer will support the Head of Bulk and/or Packaging Operations in monitoring quality and performance metrics and act as a referee for the operational team for GMP systems, documentation, and training. Furthermore, the Senior Compliance Engineer will act as deputy to the Head of Bulk and/or Packaging.
Key Responsibilities
- Author, own, and lead updates of GMP documents related to Bulk and/or Packaging Operations.
- Initiate and own deviations related to Bulk and/or Packaging Operations.
- Lead investigation tasks as required.
- Support the Head of Bulk and/or Packaging Operations in monitoring quality and performance metrics.
- Act as a referee for the operational team for GMP systems, documentation, and training.
- Act as deputy to the Head of Bulk and/or Packaging.
Requirements
- BS/MS in Engineering/Technical discipline or equivalent experience.
- 8 years' experience in pharmaceutical validation, packaging, or related field.
- 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.
