QA研究员 招聘
无锡药明康德新药开发有限公司上海分公司
招聘日期 :
2008-07-03
～
2008-09-01
工作性质：全职
工作地点：上海
工作经验：二年以上
外语要求：英语/良好
：：要求及待遇：：
工作性质：全职
工作地点：上海
工作经验：二年以上
：：要求及待遇：：
职位描述及要求：
Main Purpose and Objectives of Position:
To be assure that all operations implemented in BAS laboratory are compliant to FDA GLP
regulations and company SOPs.
To assistant QA manager on quality system construction, maintaining and continues improvement.
Personal Considerations:
Health in good condition
At least one year QA experience in GLP or GMP
Educational Requirements:
Minimum Bachelor degree, major in Chemistry, pharmaceutical or equivalent
License/Certificate Requirements:
Trained or have experience in EPA and FDA GLP regulations is plus.
Key Responsibilities:
1.Responsible for assuring that laboratory areas use qualified equipment and utilities, validated
software and appropriately validated methods for their use.
2.Audit study protocol and associated amendments generated by Bioanalytical Sciences
department (BAS).
3.Inspect each study at intervals adequate to assure the integrity of the study.
4.Report any significant problems which are likely to affect the integrity of a study immediately
to the study director and management.
5.Prepare written reports and submit them to management and the study director noting any
problems found during the course of an inspection.
6.Assure that deviations from approved protocols or standard operating procedures are made
with proper authorization and documentation.
7.Audit the final study report and report amendment and assure that the report accurately
describes the methods and factually reflects the raw data of the study.
8.Conduct routine nonclinical laboratory inspection and report any significant deviation from
standard operation procedures to laboratory management and follow up corrective actions.
9.Review new and revision of standard operation procedures from BAS/PAS/Service Biology to
assure compliance with FDA and OECD GLP regulations.
10. Write new standard operation procedures for QAU and conduct periodic review and make
appropriate revision as necessary.
薪 水：面议
元（不包括奖金、佣金、年薪、股票、期权等奖励性收入）
