Supplier Audit and Oversight Manager
辉瑞制药有限公司
- 公司规模:5000-10000人
- 公司性质:外资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2013-05-14
- 工作地点:上海
- 招聘人数:若干
- 工作经验:五年以上
- 学历要求:本科
- 语言要求:普通话熟练
英语良好 - 职位类别:采购材料、设备质量管理
职位描述
工作职责:
1. As assigned, independently conducts visits to raw material suppliers to evaluate the following:
a. Adherence to the concepts of cGMPs and compliance with requirements in the quality agreement and with Pfizer expectations.
b. Continued adequacy of the facilities and equipment being used for manufacturing.
c. Management attitude toward compliance with applicable requirements.
d. Review the turnover of employees and assess whether employees are being properly trained for their responsibilities.
e. Weaknesses that could lead to manufacturing and distribution of products in violation of the relevant laws and regulations.
f. Assuring that the supplier is executing all activities (manufacturing, testing regulatory compliance) per Pfizer agreements.
g. Communicate relevant quality, EHS and business information to the supplier in an effort to maintain and enhance the relationship between the supplier and Pfizer.
2. Participate in Pfizer audits at the supplier. Responsibilities for this activity include:
a) Assisting in scheduling the audit.
b) Actively participating in the audit as directed by the lead auditor.
c) Review the audit report to the supplier and assist in developing acceptable remediation plans.
d) Performs a follow-up as needed or as directed by PGM leadership
3. Maintain the appropriate database with any relevant information pertaining to the supplier.
4. Maintain and expand current knowledge of applicable laws, regulations, guidelines, and other pertinent policies, procedures, and standards that could impact the supplier.
5. Liaise between the supplier and the appropriate Pfizer group to ensure that any and all pertinent information is communicated such as any regulatory activity, any changes that are requested by Pfizer or the supplier or any pending or active regulation that may have an impact on the supplier's or Pfizer's business.
6. Take the lead with gathering information for Pfizer AQRTs or other investigations involving the supplier.
7. Support the supplier to assure rigorous investigations and promote the use of Pfizer M1 methodology.
8. Share and implement best practices across the supplier network. Facilitate training as required.
9. Conduct pre-due diligence site visits as required to determine vendor suitability.
10. Work as needed with PGM leadership and the appropriate Pfizer departments to develop a plan to be implemented at a supplier in the event that closer scrutiny of the supplier is required.
背景要求:
EDUCATION: Bachelors Degree (or local equivalent), preferably in pharmaceutical or natural sciences, or equivalent
Experience
Manager Supplier Oversight PGM: 5+ years industry or other relevant experience (including quality control/assurance, manufacturing, regulatory affairs, or product development) and auditing experience
Other Requirements
1. Familiarity with cGMPs (pharmaceuticals, foods, cosmetics)
2. Experience with working outside of Quality Operations in areas such as API manufacturing, dosage form manufacturing, packaging and EHS.
3. Familiarity with the Chinese culture and Chinese business environment
4. Fluency in Chinese
5. Familiarity with web based databases and computer systems
6. Problem solving ability (ability to recognize symptoms of problems or situations that require further evaluation, analyze symptoms to determine potential causes, suggest possible corrective actions)
7. Excellent oral and written skills in Chinese. Knowledge of English is desirable
8. Strong interpersonal skills
9. Ability to work with and retain information of a confidential nature
10. Ability to travel (40%)
简历收集邮箱为:dlrecruit@pfizer.com
公司介绍
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.
联系方式
- Email:chinahrwest@Pfizer.com
- 公司地址:南京西路中信泰富