QA Specialist
Vor 2 Tagen
Sankt Pölten, Österreich
Hays Österreich GmbH
Vollzeit
Deine Rolle im Team - Perform gap assessment with QA team to identify requirements of USDA regulations versus the current GMP practices at the site
- Following the gap assessment, a CAPA plan needs to be established and implemented to prepare the site for USDA pre-approval inspection
- Development of CAPA plan
- Supporting approval of assessment and CAPA Plan
- Exceptional knowledge about EU GMP and USDA -requirements is a must
- Exceptional knowledge in the areas of qualification and validation of building, utilities, equipment, manufacturing processes and analytical and microbiological methods
- Project management knowledge, leadership capabilities with respect to quality topics
- Solid experience in pharmaceutical Quality Assurance
