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Qualification Expert

vor 3 Monaten


Basel, Basel-Stadt, Schweiz Randstad Professionals Vollzeit
For one of our Clients, a company based in Kaiseraugst, we are looking for a Qualification Expert.


The perfect candidate is an experienced qualification expert with several years of hands-on experience in qualification within a GMP environment, preferably the pharmaceutical industry.


General Information:

  • Start date: ASAP
  • Latest Start Date:
  • Planned duration: 12 months
  • Extension: possible
  • Workplace: Kaiseraugst
  • Workload: 100%
  • Remote/

Home Office:
max. 20%

  • Travel: no
  • Team: 10 people
  • Working hours: Standard

Tasks & Responsibilities:

  • 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

Must Haves:

  • Technical degree or relevant work experience in qualification with GMP
  • Further training and handson experience in the area of GMP
  • Min. 35 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 is a must
  • Experience with Siemens COMOS, EVAL and VIVA is a plus
  • Fluency in German spoken and written needed, English fluency written and reading comprehension
  • Very independent and structured way of working with a selfimage of self and to continuously improve the processes
  • High degree of initiative, flexibility and quick comprehension skills
  • Enthusiasm for working together in selforganised teams and for your own areas of responsibility areas of responsibility with a focus on the big picture