Qualification Engineer in the Field of Drug Substance
- 22 September 2026
- 100%
- Temporary
- Basel
About the job
Company DescriptionFlexsis is a company of the Interiman Group, one of the leading providers of personnel services in Switzerland. Thanks to our solid expertise and the competencies within the Interiman Group, we offer customised solutions in personnel consulting.
For our client Roche in Basel we are looking for a reliable and motivated (m/f/d)
Qualification Engineer in the Field of Drug Substance
Start date: 01.10.2026
Latest possible start date: 01.12.2026
Planned duration of employment: 1 year
Extension: likely
Workplace: Basel
Workload: 80-100%
Home office: partially yes, at least 3 days per week on site
Job Description
- Creation of concepts, QPP (Qualification Project Plan) or VMP (Validation Master Plan)
- Creation of qualification/validation plans/reports for all phases according to Roche quality system
- Execution of qualifications/validations in all phases according to 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 encountered
- Development of solution proposals for the deviations encountered
- Familiarisation with electronic qualification and validation software
- Degree in a natural science/engineering field or relevant professional experience.
- At least 3 years of professional experience and solid 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 lean implementation of GMP requirements
- Good knowledge of the topic "Data Integrity"
- Very good German skills in spoken and written form, good English skills
Have we aroused your interest and would you like to seize your chance? Then we definitely should get to know each other! Simply click on "Apply now" and we look forward to receiving your complete application documents.
