Qualification Engineer (m/f/d) in the area of Drug Substance

Tasks & Responsibilities:

• Creation of concepts, QPP (Qualification Project Plan) or VMP (Validation Master Plan)
• Creation of qualification/validation plans/reports for all phases according to the Roche quality system
• Execution of qualifications/validations in all phases according to the Roche quality system
• Assessment of technical changes to equipment regarding impact on the qualified state and independent processing of requalification activities
• GMP-compliant documentation of the work performed and summary of deviations that occurred
• Development of proposed solutions for the deviations that occurred
• Familiarization with an electronic qualification and validation software

Must Haves:

• Degree in a natural science/engineering course of study or relevant professional experience.
• Min. 3 years of professional experience and sound experience in the qualification process
• Practical professional experience with qualifications/CSV of various types of equipment/systems and rooms/media
• Several years of experience in the GMP area with in-depth understanding of quality systems and the lean implementation of GMP requirements
• Good knowledge in the topic of “Data Integrity”
• Very good German language skills in speaking and writing, good English skills

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