南平招聘

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产品处置放行方面的战略目标。
Develop and execute site Product disposition objective as per site and Pfizer global quality objective.

2. 建立工厂物料取样，检查和放行管理体系，并有效执行，以确保只有符合GMP要求和质量标准的物料才能用于生产。包括但不限于：原辅料的取样检查发行；内外包材的取样检查发行；无菌生产用关键耗材的取样检查放行，仓库接收过程发现的物料问题的处理等。
Establish and maintain Site material sampling, inspection and disposition management system, and effectively implement to ensure only materials that meet cGMP requirements and quality specification are release for production. It includes but not limited to: Raw material and excipients sampling, inspection and release; Primary and secondary PKG components sampling, inspection and release and Sterile operation key consumable material inspection and release; Disposition of material issue found during warehouse receiving etc.

3. 建立物料供应商投诉管理程序，确保供应商导致的物料问题得到及时有效的解决，和供应商紧密联系持续维持并改进物料的表现。包括但不限于：建立物料表现数据库；及时建立物料供应商投诉记录；跟进供应商问题的调查；审核供应商调查报告及整改行动计划；物料表现趋势分析等；
Establish Material complaints management procedure, to ensure all material issue that caused by supplier is handled and resolved effectively in a timely manner. Keep close connection with supplier to maintain and continuously enhance material performance. It includes but not limited to: establish material performance database; Document material complaints in a timely manner; Follow up on supplier investigation progress; review supplier investigation report and CAPA; Perform material performance trends analysis etc.

4. 建立生产批记录审核程序，并负责生产主批报的审核批准和生产批记录的审核，确保生产主批报以及批记录符合产品工艺规程，注册工艺，cGMP，以及PQS的要求。
Establish production batch record review procedure, and is responsible for production master batch sheet and batch record review and approval, to ensure production master batch sheet and batch record is consistent with product process description, registered process, and compliant with cGMP and PQS requirement.

5. 建立在线问题处理程序，在收到生产线质量相关问题的报告时，负责及时有效地对生产线相关问题作出正确的处理，保证产品质量，并符合cGMP和PQS的要求。
Establish on-line problem solving procedure, responsible for effectively handle on-line problem in a timely manner when it presents, to ensure product quality and compliant with cGMP and PQS requirement.

6. 建立并执行DS原液放行和DP成品放行控制系统，确保只有符合产品放行质量标准， cGMP以及PQS要求的产品才能放行，确保符合市场批准的要求。
Establish DS bulk release and DP finished goods release control system, and execute release control procedures to ensure only product that meets Release specification, cGMP and PQS requirement is released to market, and ensure product meets market authorization requirement.

7. 负责工厂事件/偏差管理体系以及产品质量投诉管理体系的建立和实施，确保事件/偏差/产品质量投诉管理标准操作程序的有效落实，包括但不限于事件/偏差数据库/质量投诉数据库的维护；发起/主导/参与工厂事件/偏差/质量投诉调查，产品质量影响评估；事件/偏差/投诉的定期趋势回顾以及持续改进；
Establishment and Execution of site event/deviation management system and product quality complaints management system, to ensure event/deviation/quality complaint management procedure is executed effectively, it includes but not limited to: Maintain event/deviation/complaint database; Initiate/lead/participate site event/deviation/complaint investigation an product quality impact assessment; Trends analysis for event/deviation/quality complaint and continuous improvement etc.;

8. 建立年度产品质量回顾程序，并有效执行产品年度质量回顾以及持续改进，确保按计划完成年度回顾，并符合cGMP和PQS的要求，包括但不限于：按照PQS的要求制定年度产品质量回顾的具体内容；制定年度产品质量回顾计划；按计划执行年度产品质量回顾；趋势分析并及时采取有效措施 等。
Establish Annual product quality review procedure, and enable effective execution and continuous improvement, to ensure product quality review is performed as planned to meet cGMP and PQS requirement. It includes but not limited to: Define product quality review content as per PQS; develop annual product quality review plan; perform product quality review as planned; trends analysis and take necessary CAPAs etc.

9.建立产品留样管理程序，实施产品留样管理，以确保留样的管理符合cGMP和PQS的要求，包括但不限于：建立留样取样原则；按计划获取留样；建立和维护留言库存；按计划检查留样质量等；
Establish product retention sample management procedure, and implement retention sample management procedure to ensure meet cGMP and PQS requirement, it includes but not limited to establish retention sample sampling principle; take retention samples as required; establish and maintain retention inventory; and perform retention sample inspection as planned etc.

11. 审核和批准产品和工艺相关的SOPs和相关文件，包括但不限于：物料接收，取样，检查，放行，发放相关的SOPs；DS和DP工艺相关的SOPs；产品和工艺验证相关文件等。
Review and approve product and process related SOPs and documents, it includes but not limited to: Material receiving, sampling, inspection, release and dispensing SOPs; DS and DP process related SOPs; product and process validation related documents etc.

12. 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
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;

12. 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10年或以上的制药企业质量相关工作经历，其中5年或以上生物制药以及无菌生产相关工作经历。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.