延吉招聘

为了确保产品质量以及工厂的运作符合cGMP和辉瑞质量政策的要求，在质量体系与合规经理的指导下，有效执行质量合规相关工作，维护相关质量合规管理系统。

To execute quality compliance relevant activities and maintain site Quality Compliance Management systems under guidance from Quality System & Compliance Manager, with objective of ensuring product quality and the site operations are executed in light of cGMP, Pfizer Quality Standard (PQS) and site procedures.

主要职责 Role Responsibilities

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

管理和维护工厂内审体系，确保工厂操作符合cGMP和PQS的要求，致力于持续改进工厂的质量合规水平。包括但不限于： 制定工厂内部审计年度计划，参与和协调工厂内审，内审体系定期回顾和趋势分析，工厂内审员的发展等。Manage site internal audit program, to ensure site practice compliant to cGMP and PQS requirement, and work on continues improvement of site compliance. It includes but not limited to: Develop site internal audit annual plan, coordinate and participate site internal audit, perform periodic review and trend analysis for this program, develop site GMP auditors.

推动检查就绪体系的实施，协助外部审计和检查的接待。包括但不限于制定并维护工厂检查就绪方案，维护子系统所有人及区域专家名单，跟进检查就绪方案的落实，完成体系定期回顾。Drive site Inspection readiness plan and assist external audit/inspection hosting. It includes but not limited to: Establish and maintain SIRP (Site Inspection Readiness plan), maintain a name list of site SSO and SME; coordinate the implementation of inspection readiness plan, complete periodic review of site Inspection Readiness Plan etc.

支持供应商审计，为工厂管理的供应商制定审计计划并负责实施。Support supplier audit. Responsible for developing and execute audit plan for site managed suppliers.

作为总部合规组织（如PQS小组/药典事务小组/注册部）的工厂联络人，关注药品相关法规和PQS的动向，管理工厂差距分析及意见反馈，确保工厂保持与法规的一致性。As site contact of Pfizer Global compliance functions (such as PQS team/CAG/Regulatory Affairs), pay close attention to regulatory and PQS, manage gap analysis and comments feedback at site level, ensure site practice compliant with regulation requirements.

提供相关的GMP培训，提高员工的质量意识和GMP知识。Deliver GMP training as required, to improve the employee’s GMP awareness and knowledge.

负责本地备案工作以及联络监管机构等业务，支持注册部资料准备工作如临床试验申报，产品注册等。Responsible for local filing business and communication with local regulations, and support document collection for CTA and/or NDA.

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 Qualification

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5年或以上的制药企业质量相关工作经历（至少3年及以上的生物制药或无菌生产设备，工艺验证），熟悉掌握GMP知识及其应用；Pharmaceutical, Chemical or Biological related Bachelor Degree; No less than 5 years of working experience in Pharmaceutical Quality (at least 3 years of working experience in equipment qualification or process validation of Biologics or Sterile/Aseptic manufacturing) , and proficient in GMP related knowledges;

特别知识/技能 Specific Knowledge & Skills

生物制药和无菌生产和质量管理相关知识；Biologics and Sterile/Aseptic manufacturing and quality management related knowledge;

熟悉质量风险管理，掌握相应工具的运用；Familiar with Quality Risk Management, and also the application of relevant tools.

具备产品工艺及设备验证经验；Experienced on product process validation and equipment qualification.

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。

Proficient in using English as working language at listening, speaking, writing and Proficient in Office application; 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;

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.