QA Area Specialist 质量保证区域专家

The position

Requires in-depth knowledge and experience of Aseptic production knowledge, especially isolator technology.The project QA area specialist is also responsible for driving robust Validation system and ensuring high Validation compliance level across different areas in FFEx project by applying SRV concept.The blow tasks are primarily related to FF expansion project but may be extended to other QA responsible areas when line management judges necessary.• Act as Aseptic production QA expertise to identify and mitigate GMP compliance risks during FFEx project phase, and to provide advice and conclusion to management team and line of business in all matters related to interpretations and implementation of GMP in project. • Input and Ensure program quality strategy implementation in STJ.• Risk Assessment associated with validation process as well as handling of Validation Deviations.• Across Work with program and FFEx other site QA expert to share and implemen...