Contractor Quality Assurance Architect (m/f/d)
Skills: Quality Assurance, Aseptic, Training
- Supports creation and implementation of the aseptic operator training program
- Creation and update of procedures, risk assessments, concepts
- 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 Behavior, Transitional spaces, gowning procedures)
- Implementation of state of the art VR technology for aseptic operator training
- Language: German and English Business Level
- Education: Degree in Life Sciences Experience
- 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.