For our client, a leading global biotech company with location in Bern, we are currently looking for a Quality Assurance Architect (m/f/d).The ideal candidate will have previous experience 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.Main responsibilities:
Supports creation and implementation of the aseptic operator training program for the site Bern
Creation and update of procedures, risk assessments, concepts
Ensure adherence to global 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
Minimum Qualifikation
Bachelor's degree in Life Science or equivalent practical experience.
At least 5 years working 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.