. Quality assurance and quality monitoring activities:
质量保证和质量监督活动：
a) On-site monitoring:
现场监控：
61 Organize production on-site supervision of production areas involving, preparations to ensure that the production, validation processes are carried out according to established procedures and that all necessary controls for intermediate products are effectively implemented, reviewed and reported.
组织对涉及产品的生产进行现场监督，确保生产过程、验证过程按既定规程进行，所有对中间产品必要的控制被有效地执行、复核和报告。
61 Supervise the process of commissioned production to ensure the quality accuracy and reliability of commissioned products (if applicable)
监督委托生产过程，确保委托生产产品的质量的准确性和可靠性（如适用）。
b) Supervision of the implementation of the quality management system:
质量管理体系实施的监督：
61 Ensure the supervision of the implementation of the quality management system in the production area involved, and take necessary measures for existing or potential quality risks based on the principles of quality risk management;
确保监督涉及的生产区域质量管理体系的执行状况，基于质量风险管理的原则，对已有或潜在的质量风险采取必要的措施；
61 Ensure that all quality related incidents are detected in time, And participate in the investigation, grading, evaluation and report, e.g., deviations, CAPA, OOX (results out of limits, results out of specifications, results out of trends, etc.);
确保所有生产现场的质量相关事件被及时发现，并参与调查、分级、评估并上报，例如：偏差、CAPA、OOX （超限的结果，超预期的结果，超趋势的结果等）；
c) Document Review :
文件审核
61 Organize the review of documents and records related to the production and validation/qualification to ensure compliance with GMP, and registration requirements.
组织审核生产和验证/确认相关文件及记录，确保符合GMP和注册要求。
d) Any other tasks assigned by the leader.
完成领导交办的其他任务。
2. Accountable for supervising, coaching, and developing Product online QA team, ensure effective and efficient way of working.
负责监督、指导现场QA团队，确保高效的工作方式。
a) Conduct training for Product online QA Engineer to ensure product understanding.
对现场QA工程师进行培训，确保对产品理解。
b) Optimize work arrangement and improve work efficiency
优化工作安排，提高工作效率。
c) Managing team performance indicators and indicator review.
管理团队绩效指标和指标评审。
3. Product release support.
产品放行支持。
1. Have some expertise in QMS and HA inspections, some knowledge and understanding of regulatory requirement (NMPA, USFDA and EMA etc.)
在质量管理体系和HA检查方面，具有一定的专业知识，对法规要求需要一定的了解和理解（NMPA, USFDA和EMA等）。
2. Experienced in QA owned processes such as Deviation, CC, batch disposition etc...
具有QA相关流程的经验，如偏差、变更、批处置等。
3. Strong communication skills
较强的沟通能力。
4. Good business relationships
良好的业务关系。
1. Minimum 8 years of general experience in the pharmaceutical industry. 3 years’ experience in quality systems required with 3 years working experience in biologics production and management.
至少8年制药行业工作经验，3年以上QA管理经验，3年以上生物制品制剂生产及管理相关工作经历。
2. Fluent speaking, writing and reading ability in English
流利的英语口语、书写和阅读能力。
3. Proficient in using Office software
能够熟练运用Office办公软件。
1. Bachelor of Science Degree or above
理学学士及以上学位
2. Pharmacy, Chemistry, Biochemistry and equivalent is prefer
药学、化学、生物化学及相关学科优先