JobdescriptionFor our client, a leading international pharmaceutical company in Switzerland, we are seeking a Qualification Expert.General Information:Start date: ASAPDuration: 12 months, with the possibility of extensionWorkplace: KaiseraugstWorkload: 100%Team: 25 peopleDepartment: Qualification (MMMCGE)Working hours: StandardRemote/Home Office: max. 20%About the job:The Qualification Unit of Engineering and SHE at the Kaiseraugst site is seeking reinforcement for the qualification of Embedded Systems. Embedded Systems are production facilities with embedded process automation systems, such as SCADA/HMI.The perfect candidate: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.Tasks & Responsibilities:Responsible for planning and conducting qualification and validation activitiesCreating and reviewing qualification and validation documents (DQ, IQ, OQ, PQ)Carrying out and documenting qualification processes for our Embedded Systems / process automation systems according to cGMPDeveloping, implementing, and conducting test strategies, test plans, and test cases to verify system performance and complianceProviding expertise in creating specifications (e.g., URS).Working with IT, process engineering / automation, quality assurance, and production departments to ensure smooth integration and qualification of the systems.Handling qualification impact assessments as part of change or deviation process management.Collaborating closely and communicating intensively with other departmentsProviding assistance in the processing of deviations, changes and CAPAsMust Haves:Technical degree in a relevant fieldFurther training and hands-on experience in the area of GMPMin. 3-5 years of experience in the qualification and validation of machines and processes, preferably in the pharmaceutical industrySeveral years hands on work experience in qualificationExperience with Siemens COMOS, EVAL (ValGenesis) and VIVAFluency in German spoken and written needed, English fluency written and reading comprehensionVery independent and structured way of working with a self-image of self and to continuously improve the processesHigh degree of initiative, flexibility and quick comprehension skillsEnthusiasm for working together in self-organized teams and for your own areas of responsibility areas of responsibility with a focus on the big picture If this role feels like the perfect fit for you, don't hesitate - apply today! We look forward to receiving your application!Walentyna Dobrowolska