Essential Duties and Job Functions:

o Releasing products of API and GMP intermediate produced in CMOs, including BPR review, deviation investigations, process validation, change control, product disposition on Gilead systems.

o Preparing quality relevant documents such as APQR, site qualification, validation report, etc.

o Visiting CMOs, including visit preparing, report generating, and CAPA follow-up.

o Supporting site audits for component suppliers (critical raw material and API), including audit preparing, audit preforming, audit report issuing, and CAPA follow-up.

o Evaluating and providing constructive suggestions for the compliance of CMOs’ quality system.

o Supporting and communicating with CMOs and Gilead relevant function departments on projects.

Knowledge, Experience and Skills:

o Good knowledge and understanding of quality standards, rules and regulation for critical raw materials (CRMs) and APIs, including but not limited to: US cGMP, ICH Q7, EU GMP, and ISO9001.

o Capable of evaluating the compliance of quality systems and identifying risks to quality and business.

o Good verbal and technical writing skills in English and excellent interpersonal skills.

o A BS degree in chemistry or relevant areas,

o A minimum of 3 years of operational quality assurance experience in a pharmaceutical API manufacturing environment.

o Experience on conducting and documenting deviation investigations. Audit experience would be a plus.

上班地址：虹桥