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职位信息

职位信息
QA Project Leader
May. 17, 2021
QA Project Leader
中国
杭州
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.
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.