QA Specialist

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

Unsere Erwartungen an dich:

Qualifikationen

• 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

Erfahrung

• Solid experience in pharmaceutical Quality Assurance