岗位职责:

Job Description

1. Experienced in GMP quality management and improvement

2. Able to handle regulatory inspections from FDA, EMA, NMPA etc and GMP audits from clients as well as internal quality assurance unit

3. Lead GMP investigations and provide guidance/direction to the team for investigations

4. Play a role in critical and major quality related issue detection and associated trouble-shooting and investigation.

5. Involve to assist solving key quality issues as requested by the team.

6. Experienced in cross-functional communication.

任职要求:

Qualification

1. Master degree or equivalent in Analytical or other directly related science discipline with pharmaceutical industry experience of no less than 8 - 10 years in quality related position.

2. Proven good track record of accomplishments in the quality management area

3. Fluent oral English communication skill.