质量控制高级专员
职位描述
Accountability:
一、Local GCP Support and Quality Management Activities
1、Prepare and conduct study/internal system quality checks, such as study File Review, On-Site Quality Visit and staff qualification system review.
2、Set up/maintain study quality metrics and QC plan with project team
3、Maintain ACN Development Division staff qualification system
4、Serve as local helpdesk for GCP issues and questions
二、SOP Management and Training Activities
1、Support local SOPs development and update according to related laws, regulations and company requirement.
2、Facilitate implementation of global and local SOPs and policies for the conduct of clinical trials.
3、Provide training of GCP, SOP and local clinical trials related regulations for new and existing staff.
三、Inspection/Audit Support
1、Support project team for inspection/audit preparation
2、Draft/review the response to inspection/audit report
3、Follow up CAPA
4、Share inspection/audit results within ACN Development Division
Qualifications:
1、Graduate in Medicine, Biology, Science, Pharmacy, Nursing or other Life Sciences disciplines
2、Demonstrated communication, negotiation/influencing, and social skills with a sense of diplomacy, relating to peers.
3、Good active and passive skills in English, leading and attending meetings, presenting and training.
4、Working knowledge of China drug development processes.
5、Understanding the impact of regulatory requirements and guidance’s / internal SOPs / PM concepts.
6、Works effectively under pressure, accurate and patient.
7、Proficient in utilizing and creating outputs using relevant software. Easily adapts to change.
8、3 years working experience in CRA.
9、 Medical or pharmaceutical knowledge.
10、Teamwork, relevant computer skills and organizational training skills.
51金融圈为求职招聘者提供安斯泰来制药(中国)有限公司质量控制高级专员职位,薪资:15k-20k,地点:北京市,更有质量控制高级专员的职位描述、相似职位等等介绍信息。