QA经理（新界沙田科技园办公）

职务目标概述 组织作用： 作为新药研究阶段的质量管理人员。 Organizational Role : Quality Management personnel for new drug development. 协作关系： 委托研究机构（审核合规性）、珠海公司QA部（分工协作）；CMC中心、生产中心、临床中心等。 Collaborative Relationships : Contract Research Organizations (for compliance auditing); Zhuhai Company QA Department (coordinating work); CMC Center, Manufacturing Center, Clinical Center, and other internal stakeholders. 核心目标： 独立履行放行职责并建立必要的质量体系。 Core Objectives: Independently perform product release duties and establish the requisite quality system. 岗位职责 1.产品放行决策：根据协助团队的技术审核建议，独立作出最终放行决定并签字。 Product Release Decision-Making: Independently make final release decisions and sign off, based on technical review recommendations provided by the supporting team. 2.供应商（CDMO）质量监督：作为香港公司与CDMO的日常质量对接人，负责沟通并协调协助团队进行质量问题处理。 Vendor (CDMO) Quality Oversight: Serve as the primary quality contact person between the Hongkong company and the CDMO, facilitating communication and coordinating with the supporting team for quality issue resolution. 3.质量体系建设：与协助团队建立并维护香港公司作为申办者（未来MAH）所必需的质量体系文件，例如质量手册、质量协议、产品放行程序及供应商管理等。 Quality System Development: Establish and maintain, in collaboration with the supporting team, the quality system documentation required for the Hongkong company to operate as a sponsor (future MAH), including but not limited to the Quality Manual, Quality Agreement, Product Release Procedure, and Supplier Management Procedure. 4.质量协议维护：入职后，须立即主导审核现行《质量协议》，确保其中各方的质量职责符合最终实际情况且合规。 Quality Agreement Maintenance: Upon onboarding, immediately take the lead in reviewing the existing Quality Agreement to ensure that the quality responsibilities of all parties are aligned with the actual operational setup and remain fully compliant. 任职资格 一、学历/专业证书 Education/Professional certifications 至少具有药学或相关专业本科学历（或中级专业技术职称或执业药师资格）。 Bachelor's degree or above in Pharmacy or a related discipline (or intermediate professional technical title, or licensed pharmacist qualification). 具有相应的专业知识（微生物学、生物学、免疫学、生物化学、生物制品学等），并能够在生产、质量管理中履行职责。 Possess relevant expertise in microbiology, biology, immunology, biochemistry, biopharmaceutics, or equivalent fields, with the capability to perform duties in production and quality management. 二、工作经验 Work experience 具有至少五年从事药品研发或药品生产质量管理工作的实践经验，其中至少有一年的药品质量管理经验。有生物药质量管理经验者优先。 Minimum of five years of hands-on experience in pharmaceutical R&D or production/quality management, including at least one year of quality management experience. Experience in biologics quality management is preferred. 接受过与所生产产品相关的专业知识培训。 Received training in technical knowledge relevant to the products manufactured. 三、专业技能 Technical skills 熟练使用Office 办公软件。 Proficient in Microsoft Office Suite. 四、软技能 Soft skills 具备较强的细节把控能力、合规意识，良好的沟通协调能力。 Strong attention to detail, robust compliance mindset, and excellent communication and coordination abilities.