SciClone Pharmaceuticals qa jobs (salary & requirements)

MMain Duties Responsibilities 主要职责ain Duties Responsibilities 主要职责
1. Establish improve the companys quality management system, be responsible fquality assurance.
2. Developed audit plans, conducted regular audits of the companys internal clinical trial operation management as well as vendors related to the project, submitted audit reports, summarized audit findings. Ensure that the design, conduct, monitoring, recording, analyses, reporting of clinical trials meet all applicable regulatory standards, the rights safety of trial subjects are protected, that data are valid reliable.
3. Assist the government regulatory authorities in the inspection of clinical trials.
4. Acts as QA representative expertise to provide quality continuous improvement consultation support internally.作为 QA.
5. Management of Clinical product：To confirm approve the labeling of clinical products from a regulatory perspective.
6. Handle the other ad hoc tasks as required by Superiors.
Qualifications / Requirements 任职资质/要求
1. Bacheldegree above in life science related majors.
2. Familiar with GCP regulations related requirements.
3. 10 years more of clinical research related work experience, including 6 years of QA experience.
4. Good skills in written &al communication in English are mandatory.
5. Good communication skills towards to internal external.
6. Skills fcauses analysis trouble-shooting.
7. Scientific, rigorous careful, self-motivated, active, accountable.
8. Willing to improve the quality of clinical research through the implementation of relevant quality systems, while gaining personal grow.