商丘招聘

职位描述：

职责范围
Position Responsibilities

1. 根据辉瑞总部的质量目标制定并执行工厂质量与合规方面的战略目标。
Develop and execute site Quality compliance objective as per Pfizer global quality objective.

2. 建立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。管理法规与公司质量政策/指南的合规性分析，合规行动的制定与管理；
Establish and maintain Site Quality Compliance system and develop site CAPA management system, to ensure site Procedures/Instructions meet cGMP and PQS requirements. Follow up the latest applicable Regulations and PQS update, and manage the compliance gap analysis and application system to ensure appropriate actions are defined and tracked to compliance if any gaps are identified.

3. 支持物料管理系统所有人建立并执行物料供应商管理体系 ，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理要求，包括但不限于供应商的选择，评估，绩效管理，质量协议和变更控制等。
Support Material system owner to establish and execute material supplier management system, to ensure suppliers are managed as per criticality and risk of materials, it includes but not limited to Supplier selection, evaluation, performance management, Quality Agreement and change control etc.

4. 参与工厂验证管理体系的建立和维护，并监督工厂验证管理体系的有效执行，确保符合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，清洁验证计划，工艺验证计划，自动化系统验证计划等；支持在验证和设备表现回顾；审核/批准 GMP相关验证文件和相应SOPs；
Participate the establishment and maintenance of site validation management system and oversee the execution, to ensure site validation management meets cGMP and PQS requirements. It includes but not limited to: Develop/review project/site validation master plan, e.g. Utility and equipment qualification plan, cleaning validation plan, process validation plan and Automation validation plan etc.; Support revalidation and Equipment Performance Review; Review/approve GMP related validation/qualification documents and SOPs.

5. 建立质量风险管理体系，起草项目阶段的质量风险管理计划，明确质量风险管理的策略，制定识别，评估，控制，报告和沟通质量风险的方案，并协调工厂质量风险管理计划的具体实施，确保质量风险管理符合cGMP和PQS的要求；
Establish Quality Risk Management system, develop QRM master plan for project phase, and define QRM strategy, develop process for risk identification, evaluation, control, report and communication, and coordinate the execution of site QRM master plan, to ensure site QRM meet cGMP and PQS requirement;

6. 建立工厂审计管理体系，并对工厂项目阶段 以及日常生产运营阶段的合规性进行监督管理，确保符合cGMP和PQS的要求 。包括但不限于： 制定工厂内部审计和供应商审计的年度计划；对工厂的测试、制造、加工，包装、仓储、发运以及供应商的运作进行定期审计，确保符合cGMP的要求；协调辉瑞总部审计和相关药监机构的检查；审核并批准工厂内审和供应商审计缺陷和整改行动等；
Establish site audit management system, and monitor the quality compliance performance throughout the project phase and routine operation, to ensure compliant to cGMP and PQS requirement. It includes but not limited to: Develop site internal audit and supplier audit plan; Conduct periodical audit to test, manufacturing, processing, packaging, storage and distribution and suppliers to assure compliance; Coordinate Pfizer global audit and Regulatory agency inspection; Review and approve site internal audit and supplier audit report and CAPA plan etc.

7. 建立工厂事件/偏差管理体系，确保事件/偏差管理标准操作程序的有效落实，包括但不限于建立事件/偏差数据库；发起/主导/参与工厂事件/偏差调查；事件/偏差的定期趋势回顾等；
Establish site event/deviation management system, to ensure event/deviation management procedure is executed effectively, it includes but not limited to: Establish event/deviation database; Initiate/lead/participate site event/deviation investigation; Trends analysis for event/deviation etc.;

8. 建立工厂变更控制体系，确保有有效的标准操作程序指导变更的管理和控制的，并监督和协调工厂变更控制流程有效实施。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。
Establish site change control system, to ensure effective procedure is in place for change management and control, and oversee and coordinate the execution of site change control procedure. It includes but not limited to: Initiate/review/approve change related document; Ensure appropriate action is defined as per risk assessment;

9.建立GMP认证检查就绪计划，并协调GMP认证准备计划的实施，包括但不限于及时了解相关法规动态；明确申报临床试验，生产许可证，GMP认证申请所需具体文件资料等；建立GMP认证检查相关核心工作的具体的准备计划；
Establish Inspection readiness plan, and coordinate the execution of inspection readiness plan within site, it includes but not limited to understand latest regulation trends and regulatory process map; Specify document requirement of Clinical application, production license and GMP certificate application etc.; Establish specific Inspection preparation plan for key GMP elements etc.

10. 团队管理：营造安全、开放、主动、学习和注重合规的工作氛围；确保小组成员在工作中符合公司政策和行为规范的要求；通过有效沟通和指导，确保小组目标与部门目标和工厂目标一致，并高质量的完成工作目标；明确小组成员在业务能力和领导能力上的发展需求，为小组成员创造学习与发展的机会，持续为部门和工厂培养人才。
Team Management: Create Safe, Open, Initiative, Learning and Compliance orienting working atmosphere; Ensure team member follow company policies and behavior expectation; Through effective communication and Coaching, to ensure individuals objectives are align with Quality and Site objectives; Understand people development needs on Business & Tech. skills, and leadership skills, and create appropriate opportunities for people development, to continuously build talent for Quality and Site;

11. 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
教育程度/经验：

具有药学，化学或生物相关专业本科学历；具有6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；
特别知识：
生物制药和无菌生产相关GMP知识
技能：
熟练的英语听说读写能力和计算机office软件应用能力；熟悉GMP管理体系的建立；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。

举报 分享

辉瑞公司（Pfizer Inc.）创建于1849年，迄今已有160多年的历史，总部位于美国纽约，是目前全球***的以研发为基础的生物制药公司。辉瑞致力于运用创新的科学技术以及全球资源来改善每个生命阶段的健康和福祉。
我们的目标是“不断创新为患者带来能显著改善其健康的药物”。我们的使命是“成为一家卓越的创新型生物制药公司”。
2012年辉瑞公司全年合计收入590亿美元，研发投入78亿美元。辉瑞在全球拥有9万多名员工，59家生产基地，业务遍及全球150多个国家和地区。2012年财富全球500强企业中辉瑞排名126位。
目前辉瑞公司的产品覆盖了包括化学药物、生物制剂、疫苗、健康药物、动物保健品等用于人类、动物和消费者保健等诸多广泛而极具潜力的治疗及健康领域，同时其卓越的研发和生产能力处于全球领先地位。
在人类和动物药品的发现、开发和生产过程中，辉瑞始终致力于奉行严格的质量、安全和价值标准。每天，分布在世界各地的辉瑞员工致力于促进当地医疗卫生的发展以及探索能够应对当今最为棘手疾病的预防和治疗方案。
辉瑞还与世界各地的医疗卫生专业人士、政府和社区合作，支持世界各地的人们能够获得更为可靠和可承付的医疗卫生服务。这与辉瑞作为一家世界领先的生物制药公司的责任是一致的。160多年来，辉瑞一直努力为人们提供更好、更优质的服务。
辉瑞生物制药目前在华上市的创新药物已超过50个，其治疗领域涵盖了心脑血管及代谢、抗感染、中枢神经、抗炎镇痛、抗肿瘤、泌尿、疫苗及等诸多领域。其中如立普妥®、络活喜®、万艾可®、舒普深®、希舒美®、沛儿®、索坦®许多产品在市场上处于领先地位。为了让中国的广大患者能及时接受与全球同步的先进的药物治疗，辉瑞未来将进一步加大和加快在华新药引进和上市的力度和速度。
辉瑞健康药物旗下的善存®、钙尔奇®、惠菲宁®等消费保健产品也在中国市场家喻户晓，并以其优异的品质深受广大消费者的青睐；辉瑞旗下的硕腾动物保健品*为中国的动物保健市场提供各类领先的动物疫苗和动物药品。

At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products of healthcare industry and many of the world's best-known healthcare products such as Centrum. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world's leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 160 years, Pfizer has worked to make a difference for all who rely on us.