Qualification Expert

• Responsible for planning and conducting qualification and validation activities
• Creating 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 cGMP
• Developing, implementing, and conducting test strategies, test plans, and test cases to verify system performance and compliance
• Providing 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 departments
• Providing assistance in the processing of deviations, changes and CAPAs

• 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 ValGenesis 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

Are you interested and would you like to seize this opportunity? Then we should definitely get to know each other!  Simply click on "Apply now" and we look forward to receiving your complete application documents.