QA Function Leader-无锡

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

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