东莞招聘

工作职责:

Our Quality Operations Mission is “to be a proactive partner, driving a science and risk-based compliant quality culture that is flexible, innovative, and customer oriented, maximizing the contribution of Quality Operations to Our Path Forward initiatives.”

Being part of Quality Operations, SCES Quality is responsible for the Quality management of approximately 150 contract manufacturers, packagers, and supply partners globally that support Pfizer Biopharmaceuticals Group.

The Manager QS&OS is accountable for a variety of Quality Systems and Operational Support activities.

This is an independent position operating and interacting with high levels of management both at contract manufacturers and within Pfizer. In this role the colleague operates as point of contact for driving the Quality Systems and Operational support activities and will spend a significant period of time developing relationships, independently negotiating, developing and communicating Pfizer regulatory requirements with contract manufacturers. The QS&OS Manager will provide regulatory and complaint expertise for Classic VSOT’s. In this role the colleague will need to make decisions that may require developing new options to resolve complex problems as well as making decisions guided by policies in non-standard situations. The colleague also need to operate independently in ambiguous situations within department. The QS&OS Manager will have significant interactions with many internal business and manufacturing organizations (e.g., ES, GRA, GTE ) and will lead virtually based cross functional teams.

The Manager will be responsible for regulatory change management activities as a Site Compliance Network Member (SCNM) and management of routine product complaints for the Drug Products and Drug Substances (APIs) manufactured by Contract manufacturers which supply Innovative Medicine Business.

Responsibilities:

Initiate, review and approve regulatory changes through PDM for changes initiated by or impacting managed Contract manufacturers.

Provide support for the closure of the deficiency letters and CMC Commitments, Regulatory requests for Renewals, New Product registrations and Post approval variations.

Serve as the main point of contact for the Global Chemistry, Manufacturing and Controls (GCMC) department or Local Regulatory Affairs in the Pfizer Country Offices (for Single market products) for the various regulatory activities involving SCES Quality managed Contract manufacturers.

As the Regulatory Compliance and Product Complaint Expert, participate in Virtual Site Operating Teams (VSOT) (or similar) meetings for SCES Quality managed Contract manufacturers and if needed, participate in Site Quality visits at the Contract manufacturers.

Manage routine Customer Quality complaints for commercial Drug Products in PCOM and work in collaboration with the SCES Quality - Contractor Quality Lead for ensuring that the investigation reports are appropriate and acceptable. Ensure timely closure of complaints and "alert"ing the appropriate colleagues as per our procedure and Standard Work guidance.

Support and Perform Lot Endorsement for Biotech products in collaboration with other functions.

Provides guidance to and/or lead projects. Manages own time to meet objectives; forecasts and plans resources for projects

任职资格:

Min. BA/BS in Science, Engineering, Pharmaceutical Sciences or related technical discipline;

Min. 8 years of experience in GXP setting and/or Regulatory Affairs role (or 4 years with Master degree) ;

At least 4 years of Product Quality Assurance experience in a GMP environment ;

Advanced in computer skills such as MS Office applications and good knowledge of enterprise systems such as PDM, QTS Trackwise, Documentum platforms;

Good command of English language and multi-lingual is a benefit;

Shows strong negotiation skills and is diplomatic in communication with internal and external customers;

Strong verbal and written communication including presentation skills;

Able to report remotely and deliver work independently;

Show strong negotiation skills and customer focus;

Is diplomatic in communication with internal and external customers;

Demonstrated personal leadership to manage cross functional project;

Demonstrate ability to prioritize work, manage multiple projects, act and work independently and to report items as required to Team Leader;

Demonstrated experience managing complex quality and compliance activities in a manufacturing plant or with a contractor;

Takes initiatives and is proactive, persistent;

Supervisory experience desirable;

Up to 10% travel required;

Has a broad GMP and technical know-how to handle emerging issues;

Developing ability to resolve conflicts;

Has excellent organization skills;

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.