QA Function Leader-无锡

工作职责：

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.

人员资质：

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