Quality Assurance Architect

vor 2 Wochen


Zurich, Schweiz Swisslinx Vollzeit

On behalf of our client, an international Biotechnology company based in Switzerland, Swisslinx is looking for a Quality Assurance Architect to support the creation and implementation of the aseptic operator training program.
- Start date: June 2023
- Duration: initially 12 months
- Extension: possible
- Mostly remote work (based in Switzerland)
- Workload: 100%

Your mission:

- Creation and update of procedures, risk assessments, concepts
- Ensure adherence to global company procedures and standards
- Creation of training content in the area of aseptic processing (Microbiology, Hygiene, Aseptic Behaviour, Transitional spaces, gowning procedures)
- Training of operators for the aseptic processes and manufacturing in the area (Microbiology, Hygiene, Aseptic Behaviour, Transitional spaces, gowning procedures)
- Implementation of state of the art VR technology for aseptic operator training

Your Profile:

- Education: Degree in Life Sciences preferred
- Business level or German and English
- Demonstrated strong technical knowledge in the areas of sterility assurance of aseptic cleanroom facilities, their processes and equipment, and personnel to include design and use and life cycle management and cGMP compliance
- +5 years of experience in the pharmaceutical manufacturing industry with direct experience in sterility assurance of aseptic processing
- Extensive professional experience in leading teams with respect to aseptic cleanrooms, process, equipment, consumables, aseptic behaviors and gowning and utilities
- Demonstrated experience in quality assurance and regulatory compliance with GxP, FDA, EU and other regulatory agency guidelines



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