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Manufacturing Compliance Expert

vor 1 Woche


Neuenburg, Neuenburg, Schweiz Gi Group SA Vollzeit

**About Gi Group SA**

Gi Group SA is a global ecosystem of HR services and consulting that supports the development of the labour market.

We are a leading staffing company in the Swiss recruitment market, operating in 35 locations across Switzerland with over 250 employees.

We believe in experts talking to experts, which is why all our professionals are certified in scientific sectors.


**Job Description**

We are looking for a Senior Engineer (Manufacturing Compliance) to join our team in Neuchatel.

The successful candidate will be responsible for authoring, owning and leading updates of GMP documents related to Bulk and/or Packaging Operations.

They will also initiate and own deviations related to Bulk and/or Packaging Operations, lead investigation tasks as required, and support the Head of Bulk and/or Packaging Operations in monitoring quality and performance metrics.

The Senior Engineer will act as a referee for the operational team for GMP systems, documentation and training, and will also act as deputy to the Head of Bulk and/or Packaging.


**Required Skills and Qualifications**

To be successful in this role, you will need:

  • Bachelor's or Master's degree in an Engineering or Technical discipline, or equivalent experience.
  • No less than 8 years' experience in pharmaceutical validation, packaging or a related field.
  • Knowledge of current international regulatory requirements, including cGxP, 21 CFR part 11, 210 and 211, Annex 11, EU-GMP guidelines and GAMP.
  • Experience in Health Authority inspections, including preparation, process, presentations and response drafting.
  • Knowledge of pharmaceutical facilities, manufacturing and laboratory systems and processes.
  • Ability to work constructively 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.
  • Fluency in English and French.


**Benefits**

We offer a dynamic and supportive work environment, opportunities for professional growth and development, and a competitive compensation package.


**Why Join Us?**

We are a specialist in temporary and permanent staffing in the Life Science sector, and we pride ourselves on being a valuable partner for many other HR solutions.

We value expertise and professionalism, and we strive to provide exceptional service to our clients and candidates.