北京招聘

Responsibilities:

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.

Qualifications
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%)

大连工厂是辉瑞制药有限公司在大连开发区的生产基地，也是辉瑞全球生产集团(PGM)在中国的一个区域性供应组织。工厂占地面积82,000平方米，其中厂房设施占地20,586平方米。大连工厂拥有世界上最先进的生产设施和检测技术。产品包括多种片剂、粉针剂、粉剂和胶囊等多种剂型的制剂药。工厂率先于1997年4月获得国家GMP认证委员会颁发的中华人民共和国第0001号GMP认证证书，其综合生产能力已居国内领先水平。由于工厂拥有世界一流的检测分析手段和辉瑞全球统一的完善的质量保障体系，使工厂的产品全部达到或者超过了中国药典和美国药典标准。此外，大连工厂的产品还分别于1994年、1997年、2000年和2002年通过了澳大利亚TGA检验，已获准出口日本、澳大利亚、菲律宾、巴基斯坦及欧洲等地。并于2004年4月获得由德国莱茵认证公司颁发的ISO14001环境管理体系认证证书，同时获得了中国国家认证机构认可委员会的认可。

作为辉瑞全球生产集团的一部分，大连工厂一直致力于生产高质量的创新药品，百分之百地满足客户的需求。同时，不断改进和创新，努力降低生产成本，创造并保持其在本行业内最优异的环保、健康和安全方面的业绩。