Qualification Engineer in Drug Substance

We are supporting our client in the life sciences industry with their search for a Qualification Engineer Drug Substance.

If you have experience in plant qualification in the field of Drug Substance (API manufacturing) and in the field of Computer System Validation (CSV) this might the the perfect opportunity for you!

• Creating concepts, QPP (Qualification Project Plan) or VMP (Validation Master Plan)
• Creation of qualification/validation plans/reports for all phases
• Conducting qualifications/validations in all phases according to the business quality system
• Assessment of technical changes to plants with regard to their impact on the qualified condition and independent handling of requalification activities
• GMP-compliant documentation of the work performed and summary of any deviations that occurred.
• Documented and present changes and deviations during regulatory inspections, along with the equipment qualification and CSV documentation

• Degree in a natural science/engineering
• At least 3 years of professional experience in qualification processes
• Experience in the qualification of production facilities and the validation of computer systems
• Familiar with the practical implementation of GMP guidelines
• Practical professional experience with qualifications/CSV of various types of equipment/systems and rooms / media
• Several years of experience in the GMP field with in-depth understanding of quality systems and the lean implementation of GMP requirements
• Good knowledge of the topic "Data Integrity"
• Excellent German skills (spoken and written), good English skills

Please note that we can only consider EU/Schengen applications, or valid Swiss permit.