- As quality representatives to participate in projects from early product development phase to final commercial production phase;
- Be the client single contact point for joint decision making, quality oversight, and to resolve disputes in quality matters;
- As quality representatives to communicate and negotiate quality agreement with client;
- Regular quality meeting with client for project quality oversight and quality matters discussion;
- Quality matters tracking, including but not limited to deviation\change control\manufacture documentation\material & product release；
- Escort client during visit or audit, provide clarification and prepare documentation timely;
- Support CMC project team to run projects and problems solving;
- From the clients’ point of view, support other internal teams to make decision;
- Build and maintain excellent relationships with clients;
- Support preparation of late phase Product Performance Qualification and ensure PPQ process’ GMP compliance;
- Maintain and contribute into quality system continuous improvement;
- Finish other tasks assigned by supervisor.
WuXi Biologics
Offering End-to-End Solutions
职位信息
职位信息
QA Project Leader
QA Project Leader
中国 杭州
工作职责：
任职能力：
- Bachelor or higher education level, major in bio-pharmaceutical or related subjects (including bio-technology, pharmacy, chemistry. etc);
- Profound English knowledge both written and oral;
- Excellent communication and negotiation skills;
- Good team work ability;
- Strong sense of service, decisiveness and responsibility;
- Candidates with overseas study background are preferred.