慧玲朱

Director Of Quality Assurance

About

乐观，积极，向上，追求完美，学习能力强，团队合作精神

Country

China

City

Shanghai

Industry

Pharmaceuticals

Skill

Microsoft Office, Microsoft Excel, Microsoft Word, Customer Service, PowerPoint, English, Windows, Outlook, Teaching, Public Speaking, Presentation

Experience

Director Of Quality Assurance

VISEN Pharmaceutical

2019-8 - Present · 7 yrs 2 mos

中国上海市

QC & T

JW Therapeutics

2018-5 - 2019-8 · 1 yr 4 mos

Shanghai

Process and Training Associated manager

Roche

2014-4 - 2019-5 · 5 yrs 2 mos

1. Responsible for build up a new process or optimize the current process for clinical trial and the company to ensure the compliance of local regulations/laws and ICH-GCP. 2. Work as an advisor to provide professional understanding in terms of GCP related compliance issues. Manage CAPA for clinical trials and company when audit or inspection comes. 3. Provide training for whole operation team for new staff orientation, SOP training, and other class room training session. Help to develop training materials for all training. 4. Provide support and work with regional team via participant some regional/global initiative to regarding training, process and compliance aspect.

Process and training advisor

Roche

2013-7 - 2014-4 · 10 mos

Monitor

Roche

2011-5 - 2013-7 · 2 yrs 3 mos

Work as a monitor mainly for oncology area in Roche and involved in clinical trial operation activities from investigational site start-up to close out. The main activities include initial EC submission and getting EC approval from site, site initiation visit, routine site monitoring remotely or in-field, maintaining relationship with investigaotrs during daily work, etc.