蚌埠招聘

工作职责:

？ 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.

？ 为了确保合规行动的按时完成，实施工厂CAPA管理体系，包括但不限于，在gQTS中建立和关闭行动项，跟进行动的完成情况以及对体系的定期回顾。

Implement site CAPA management system, in order to ensure site compliance actions can be completed in a timely manner, including but not limited to create and close action items in gQTS, monitoring the progress, perform periodic review.

？ 确保生产物料满足辉瑞要求并识别潜在风险，收集，汇总并分析物料信息，完成物料认证。

Collect, summarize and analyze the material information and complete material certification, in order to ensure the production material meet Pfizer expectation, and has identified the potential risk.

？ 落实供应商管理要求，参与供应商的选择，评估，绩效管理及质量协议签订。作为供应商管理的联络人，评估所有收到的供应商变更通知。

Fulfill the requirement of site supplier management, to participate in new supplier selection, evaluation, performance monitoring and also quality agreement. As site contact of supplier management to evaluate all received supplier change notifications.

？ 协助管理员管理和维护gQTS系统，包括但不限于，用户权限管理，提供技术支持，跟进变更完成情况，以及gQTS系统的问题解决等；

To support the gQTS administrator to administrate and maintain gQTS system, including but not limited: system access management， provide technical support， track change completion and also support problem solving of gQTS

？ 确保及时了解法规动向，定期浏览监管机构网站并及时将适用的更新通知工厂管理层。

Periodically visit regulatory website in order to understand the latest regulation trends. And communicate the applicable update to site management in a timely manner

？ 支持临床试验申报，产品注册，生产许可证申请等文件的收集。

Support document preparation for CTA, NDA or production application.

？ 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:

？ 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；了解GMP基础知识及其应用；

Pharmaceutical, Chemical or Biological related Bachelor Degree; understand GMP basic knowledges;

？ 特别知识/技能 Specific Knowledge & Skills

- 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;

- 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；

Fully capable of establishing GMP Quality Management System; Effective Systematical Thinking and Communication ability; Good Coordination and Collaboration; Effective execution and result driving;

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.