Qualification Expert

vor 4 Wochen


Kaiseraugst, Schweiz FLEXSIS Vollzeit
EINFÜHRUNG:
As a preferred supplier for Roche Basel in Kaiseraugst, we are looking for an individual Qualification ExpertThis is a full-time position (100%) with a 12-month contract. The ideal start date is asap. Home Office is possible up to 20%. AUFGABENBESCHREIBUNG:
  • Responsible for planning and conducting qualification and validation activities
  • Creating and reviewing qualification and validation documents
  • Producing SOPs and providing support in the creation of manufacturing specifications
  • Responsible for maintaining the qualified and validated status of rooms, infrastructure and equipment
  • Ensuring compliance with internal and external regulatory requirements with regard to qualification and validation
  • Collaborating closely and communicating intensively with other departments
  • Providing assistance in the processing of deviations, changes and CAPAs
ERFORDERLICHES PROFIL:
  • Technical degree in a relevant field
  • Further training and hands-on experience in the area of GMP
  • Min. 3-5 years of experience in the qualification and validation of machines and processes, preferably in the pharmaceutical industry
  • Several years hands on work experience in qualification
  • Experience with Siemens COMOS, EVAL and VIVA
  • Fluency in German spoken and written needed, English fluency written and reading comprehension
  • Very independent and structured way of working with a self-image of self and to continuously improve the processes
  • High degree of initiative, flexibility and quick comprehension skills
  • Enthusiasm for working together in self-organized teams and for your own areas of responsibility areas of responsibility with a focus on the big picture
Application process Interested? You can find more information here:
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