KEY ACCOUNTIBILITIES:
1.Familiar with the business model of CMO/CDMO in pre-Clinical stage;
2.Champion the effort of preparations (computerized systems only) for audits from customers and inspections by regulatory bodies and respond to findings (computerized systems only) from audits and inspections;
3.Act as the key contact person / SME for all issues related to computerized system compliance during routine quality operation, internal/external audits, health authority (HA) inspections and client communication;
4.Lead computerized system validation and quality SME and provide strategic guidance determine and establish validation requirements for computerized systems based on regulatory, IT QMS, and industry best practices, lead the development of system specific validation plans and strategy using a risk-based approach, etc..
5.In charge of the development and maintenance of the Standard Operating Procedures, Work Instructions, user guides, and other relevant documentation for IT QMS establishing and improving;
6.Conduct compliance investigation to different sites and guide team to follow standard IT compliance procedure to site IT operation;
7.Works closely with IT team in identifying, evaluating, selecting, and implementing specific information technologies that support the business plans and IT strategies;
8.Maintains a strong understanding of technology and lab/pre-clinical applications. Continuously learn new technologies;
9.As part of STA IT team, work closely with pre-clinical and discovery solution delivery directors to make the entire RND lifecycle application fully integrated;

REQUIREMENTS:
1.6+ years of working experience in Chemical / Pharmaceutical industry including 3+ years’ experiences in Computerized System Validation or other QA Function;
2.Understand Waterfall / Scrum / Agile methodology to communicate with IT teams.
3.Effective organization and time management skills, with ability to work under pressure and adhere to project deadlines and Governance in a fast paced environment.
4.Strong written and verbal communication and presentation skills. Proficient in tools like Power Point, Visio and other tools to develop process flows and presentations.
5.Quick learner and keeps current with emerging technologies in GxP space.
6.Detail-oriented with expertise in problem solving, analytical and critical thinking skills. Strong interpersonal skill in working with IT function and business leaders;

上班地址：外高桥保税区德林路90号