Qualification Engineer - Drug Substance

• Start date: open
• Planned duration: 5 years
• Contract: temporary via Randstad
• Workplace: Basel
• Workload: 80-100%
• Home Office: possible up to 2 days/week
• Working hours: Standard

Tasks & Responsibilities:
 

• Preparation of qualification plans/reports for the DQ-IQ-OQ-PQ phases according to the Quality System.
• Conducting qualifications in the DQ-IQ-OQ-PQ phases according to the Quality System.
• Preparation of QPPs (Qualification Project Plans).
• Evaluation of technical changes to systems with regard to their impact on the qualified status and independent processing of requalification activities.
• GMP-compliant documentation of the work performed and summary of any deviations encountered.
• Development of proposed solutions for the deviations encountered.
• Familiarization with electronic qualification and validation software.

• Degree in a natural sciences/engineering program or relevant professional experience.
• At least 3 years of professional experience and solid experience in the qualification process
• Fluent in German, good English skills
• Practical professional experience with the qualification of various types of systems and rooms/media
• Several years of experience in the GMP field with a deep understanding of quality systems and the lean implementation of GMP requirements
• Initial experience with data integrity is desirable