Quality Assurance Architect (5309)
Quality Assurance Architect (5309 – ADA)
Our client, a large pharmaceutical organization, is looking for a Quality Assurance Architect for a 12-month contract (with possibility for extension) in Bern, Switzerland.
- Supporting creation and implementation of the aseptic operator training program for the Client’s site in Bern
- Creating and updating procedures, risk assessments, concepts
- Ensuring adherence to global Client’s procedures and standards
- Creating 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
Qualifications and Experience:
- Relevant working/residency permit or Swiss/EU-Citizenship required
- University (or equivalent institution of higher education) degree in Life Sciences
- 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.
- Language: German and English Business Level