职位描述：
Responsibility
Purpose
Supports the Project Manager with regards to qualification and documentation issues
Major Accountability
Supply templates to project members
Assists in supplier audits and supplier instructions for qualification issues
Carries out project reviews (DQ, IQ, OQ)
Participate in Functional Risk Analyses(GMP Risk Analysis)
Writes Qualification Protocols and Qualification Reports
Writes and reviews URSs for systems
Write Test Specification Overview, Test Specification, Test Deviation list and Change requests etc.
Preparation/Support for internal and external authority inspections
Support/training of the project team members in quality relevant issues
Ensures correct completion of a qualification phase when releasing to the next qualification phase
Controlling and filling of Qualification documents according to Chapter 11
Maintain and update Qualification documents Excel list (attachment QP and QR)
Requirements
Bachelor Degree as Pharmaceutical Engineer
Experience in Qualification work is prefer
Experience in Pharmaceutical Project work is prefer
Flair for details
Persistent
Flexible personality, adaptable to changing situations
Withstand stress situations
Hard working and enthusiastic type (not only professional but also towards the country and its people)
To speak fluently English and writing
Please send your CV (in both Chinese and English) through either:
Post: No.31, Yong'an Road, Changping County, Beijing, 102200, China
Beijing Novartis Pharma Ltd.(Please mark job title in the envelop).
Fax: (010)69744887
E-mail:angie.yang@
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