JD 如下 1.POSITION:Software Quality Assurance 2.FUNCTION: IT 3.EDUCATION REQUIREMENT: Bachelors degree of equivalent experience, preferably in Computer Science or Information Systems or another discipline relevant to the life science industry. 4.MAIN PURPOSE OF JOB: To understand international and China regulations and standards, and IT SDLC(software development life cycle) that apply to IT and the business processes that are automated by IT solutions and to ensure that the solutions are developed and maintained in a validated state to the Intended Use.
5.KEY RESPONSIBILITIES: The role is responsible for ensuring that application projects are compliant to regulatory and compliance requirements. The role is expert in international and local regulations and standards knowledge and IT SDLC requirements, and provides support and guidance to project teams and management.
6.REQUIREMENTS (SKILL & COMPETENCIES):
The role must be effective with written and verbal in both Chinese and English communications at all levels, providing input and guidance to project teams. The role must be flexible to adapt to changing assignments and must be able to prioritize work effectively The role must be familiar with protocol execution practices and system certification/validation process. The role must be familiar with Good Documentation Practices and own and/or assist as appropriate with required documentation for compliance purposes. The role must be familiar with Quality Risk Management principles and practices and guide teams and management with risk-based decision-making capabilities. The