职位描述

职位描述： 主要职责 Responsibilities 根据辉瑞总部的质量目标，执行工厂质量与合规方面的战略目标。 Execute site Quality compliance objective as per Pfizer global quality objective. 建立并实施工厂质量合规管理和预防纠正措施的管理体系，确保工厂的SOP/OI符合cGMP和PQS的要求。关注法规动向，并监督实施法规与公司质量政策/指南的合规性分析，合规行动的制定； Establish and implement the Site Quality Compliance system and site CAPA management system, to ensure site Procedures/Instructions meet cGMP and PQS requirements. Responsible for regulatory intelligence, and follow up the latest applicable Regulations and PQS update, and monitor the implementation of compliance gap analysis and application system to ensure appropriate actions are defined and tracked to compliance if any gaps are identified. 支持物料管理系统所有人建立并监督物料供应商管理体系的实施，确保根据物料的关键程度和风险大小，就对应的供应商建立相匹配的管控要求，包括但不限于物料认证，供应商的选择，评估，绩效管理，质量协议和变更控制等。 Support Material system owner to establish and supervise the implementation of material supplier management system, to ensure suppliers are managed as per criticality and risk of materials, it includes but not limited to Material Certification, Supplier selection, evaluation, performance management, Quality Agreement and supplier change control etc. 作为质量代表参与工厂的确认/验证工作，确保其符合cGMP和PQS的关于验证的要求。验证相关工作包括但不限于： 制定/审核项目/工厂验证总计划，如设施设备确认计划；监督再验证和设备表现回顾的实施；审核/批准 GMP设施设备相关验证文件和相应SOPs； Participate site Qualification/Validation activities as Quality representative, to ensure site Qualification/Validation activities meet cGMP and PQS requirements. It includes but not limited to: Develop/review project/site validation master plan, e.g. Utility and equipment qualification plan etc.; Supervise the execution of revalidation and Equipment Performance Review; Review/approve GMP Facilities and equipment related validation/qualification documents and relative SOPs. 维护工厂变更控制体系，监督和协调工厂变更控制流程有效实施，确保所有影响产品质量的变更得到有效的评估和管理。包括但不限于起草/审核/批准相关变更文件，确保根据质量风险评估采取必要的风险控制措施，维护变更系统/数据库。 Maintain site change control system, oversee and coordinate the execution of site change control procedure, to ensure all changes which will potentially impact product quality are appropriate evaluated and effective controlled. It includes but not limited to: Initiate/review/approve change related document; Ensure appropriate action is defined as per risk assessment; maintain Global Change Management System or Local Change Control Database. 执行公司安排的其他相关工作； Execute any other related work assigned by company;任职资格 Job Qualification (最低任职要求 Minimum Requirements)教育程度/经验 Education/Experiences 具有药学，化学或生物相关专业本科学历；具有3年或以上的制药企业质量相关工作经历，熟悉掌握GMP知识及其应用； Pharmaceutical, Chemical or Biological related Bachelor Degree; No less than 3 years of working experience in Pharmaceutical Quality, and proficient in GMP related knowledges; 特别知识/技能 Specific Knowledge & Skills 生物制药和无菌生产相关GMP知识; Biologics and Sterile/Aseptic manufacturing related GMP knowledge; 熟练的英语听说读写能力和计算机office软件应用能力； Proficient in using English as working language at listening, speaking, writing and Proficient in Office application; 熟悉质量合规体系，具备GMP设备确认及工艺验证经验； Familiar with Quality Compliance system, and have experience in Qualification and Validation; 有效的系统思考能力和沟通技能；有效的组织协调能力和团队协作能力；有效的执行力和达成结果的能力；熟悉掌握分析问题、解决问题以及质量风险管理的理论及其工具。 Fully capable of establishing GMP Quality Management System; Effective Systematical Thinking and Communication ability; Good Coordination and Collaboration; Effective execution and result driving; Good at Problem solving and Quality Risk Management knowledge and Tool application; 职能类别： 药品生产/质量管理

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