Quality Assurance Specialist -Switzerland

Beschreibung

We have a need for a junior consultant to support GMP management systems supporting supply chain department.

Tasks:

Management of cleaning verification activities as well as support and representation of the GMP officer
Preparation of the relevant documentation (assessments, protocols and reports) for cleaning verifications related to the production of solid dosage forms in multipurpose facilities and equipment
3. Supporting cleaning verification activities on shop floor.
4. Regular updating of the cleaning validation master documents.
5. Representation and support of the GMP officer in ensuring overall GMP compliance including the handling of deviations and change controls
6. Preparation and support of internal audits and HA inspections
7. Authorship and review of production and project related GMP documents (Qualification documents, trending reports, SOPs, Logbooks)
8. Supporting and giving GMP training in collaboration with other team functions to ensure training compliance

Requirements:

• Track record of working in GMP environment and having quality- or production-related responsibilities
  *Preferably experience in the field of cleaning validation in drug product or drug substance manufacturing
  *Microbiological Knowledge is a plus
  * Strong interpersonal and communication skills; needs to be a good team player
  Fluent in German and English is must

If you are interested please call Beata Klecz on

Michael Bailey International is acting as an Employment Business in relation to this vacancy.