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Senior Manufacturing Compliance Engineer
vor 2 Monaten
We are seeking a highly skilled Senior Manufacturing Compliance Engineer to join our team at Gi Group SA. As a key member of our organization, you will be responsible for ensuring the highest standards of quality and compliance in our manufacturing processes.
Key Responsibilities- Develop and implement GMP documents related to Bulk and/or Packaging Operations.
- Initiate and own deviations related to Bulk and/or Packaging Operations, and 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.
- Assist the Head of Bulk and/or Packaging Operations as a deputy.
- 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).
- Experience in Health Authority inspections (preparation, process, presentations, responses drafting, etc).
- Knowledge of pharmaceutical facilities, manufacturing, and laboratory systems and processes.
- 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.
Gi Group SA is a global ecosystem of HR services and consulting that supports the development of the labor market and helps to change people's lives in 37 countries around the world. We operate with the brands Gi Life Sciences, Gi Group, Grafton, BauTech, and former Kelly Services. We are active in temporary, permanent, and professional staffing as well as in a variety of complementary HR Services.
We believe in experts talking to experts: all our professionals are certified in scientific sectors, meaning that they are able to understand your needs and support you at 360°.
