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本帖最后由 ibruhim 于 2013-2-22 11:56 编辑
如果有兴趣可以将CV发至
ibruhim@yahoo.com.cn
QQ 499879930
手机:13636480527
应大家的要求 我把一些要求贴出来供大家参考:
Job description - Planning, Preparing, Conducting and Reporting of GMP and Quality system audits at Third party contractors (API Manufacturers, Excipients Manufacturers, Contract Manufacturers) to monitor that all aspects of the operational business comply with applicable GMP legal and regulatory requirements (e.g. national and EU requirements) and the Group Quality Standard in close cooperation with the Corporate Audit Management Team located at Headquarter in Germany.
- Writing Audit Reports in line with the Corporate Reporting Templates
- Evaluation of audit result and reporting to Corporate Audit Management
- Monitoring that Corrective and Preventive Actions related to the audit findings are implemented appropriately and as per schedule
- Maintenance of audit data in a related data system (incl. reports and follow-up of audits)
- Support of risk assessments related to the Third Party Contractors (e.g. for supplier qualification)
- Close contact to Corporate Audit Management,
- Close cooperation and alignment with other Regional Auditors
- Support of all other GMP and documentation related questions with third party contractors
- The position will require travels within China mainly and around Asia, up to 50% of the time
Education and Experiences
- -Graduate in Pharmacy, Chemistry, Microbiology, Biochemistry or another related science preferred with technical background
- -At least 3 - 5 years of experience in the pharmaceutical, biopharmaceutical or chemical industry, e.g. in Production, Quality Assurance, Quality Control, Development
- -Experience in auditing Third party contractors according to EU GMP Guideline Part I and Part II or equivalent (ICH Q7, national)
- -Advanced knowledge of GMP guidelines and requirements
- -Good interpersonal skills, ability to work with all levels of personnel and management
- -Good problem solving and risk assessment abilities
- -Good organizational and in time management skills
- -Basic computer skills (Microsoft Office) and ability to learn and become proficient with appropriate software
- -Proven flexibility and ability to deal with multiple and changing priorities
- -English fluent in speaking and writing
- -Willing to travel around Asia with focus on China
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