Qualification Engineer in the Drug Substance area

Company Description

Flexsis is a company of the Interiman Group, one of the leading providers of personnel services in Switzerland. Thanks to our solid expertise as well as the competencies within the Interiman Group, we offer tailor-made 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 Drug Substance area

Start date:

Latest possible start date:

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 the Roche quality system
• Execution of qualifications/validations in all phases according to the Roche quality system
• Evaluation of technical changes to equipment regarding the influence on the qualified state and independent processing of requalification activities
• GMP-compliant documentation of the work performed and summary of the deviations that occurred
• Development of proposed solutions for the deviations that occurred
• Familiarization with electronic qualification and validation software

Desired Profile

• 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 different 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 "Data Integrity"
• Very good German skills in speaking and writing, good English skills

Have we aroused your interest and would you like to take your chance? Then we should definitely get to know each other! To do so, simply click on "Apply now" and we look forward to your complete application documents.

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