Duties include:
Review technical documents and provide clarification/interpretation if needed to support biologics clinical operation.
1.Provide infusion preparation training to CRO if required.
2.Provide Memo for infusion preparation, infusion bags, lines, filters and pumps, IV infusion, etc.
3.Provide interpretations and clarifications on quality concerns if required by clinical sites.
4.Review pharmacy manual and perform other duties assigned.
5.Manage quality events during drug supply and distribution process (Biologics temperature excursion, Complaint, Deviation, CAPA, etc.).

Qualifications include:
1.Bachelor’s degree in Biology, Biochemistry, Medicine or equivalents, with more than 3 years working experience in Biologics R&D and more than 2 years QA working experience is a plus, have basic knowledge on GDP, DI, GLP and/or GMP.
2.Detail orientated and result driven.
3.Fluent in English with good communication skills.
4.Team player with flexibility, strong ownership and hard-working spirit.
5.Familiar with general biology laboratory techniques and antibody techniques, have experience and knowledge in some of below technologies (e.g., PCR, cell culture, flow cytometry, western blot, ELISA, SDS-PAGE, CE, SPR, HPLC and LC/MS).

上班地址：中山三路33号中华国际中心A座15楼1507