职位描述
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ROLE RESPONSIBILITIES
Operational Excellence
* Develops audit strategy/plans for studies in China and provides input to
RQA Portfolio Leads and the head of RQA CHINA, including selecting and
identifying audit entities for China alone studies and China/Global studies.
* Support the head of RQA CHINA in developing and implementing RQA strategy
for the region.
* Keeps current with China specific regulatory and inspectional trends and
informs/advises/participates in the audit intelligence gathering process,
active participation in industry forums
* Ensures all audits are conducted in compliance with Pfizer policies,
Standards and RQA procedures, ensures audit outcomes are calibrated and driven
to completion, ensures issues are escalated, and ensures holistic remediation
plans and sustainability of CAPA
* Leads/Participates on cross functional project teams and shares knowledge
and best practices with relevant groups
* Maintains strong relationships with Pfizer R
Operational Excellence
* Develops audit strategy/plans for studies in China and provides input to
RQA Portfolio Leads and the head of RQA CHINA, including selecting and
identifying audit entities for China alone studies and China/Global studies.
* Support the head of RQA CHINA in developing and implementing RQA strategy
for the region.
* Keeps current with China specific regulatory and inspectional trends and
informs/advises/participates in the audit intelligence gathering process,
active participation in industry forums
* Ensures all audits are conducted in compliance with Pfizer policies,
Standards and RQA procedures, ensures audit outcomes are calibrated and driven
to completion, ensures issues are escalated, and ensures holistic remediation
plans and sustainability of CAPA
* Leads/Participates on cross functional project teams and shares knowledge
and best practices with relevant groups
* Maintains strong relationships with Pfizer R
工作地点
地址:中山莲花科创园
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职位发布者
车艳鑫HR
辉瑞(中国)研究开发有限公司
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制药·生物工程
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1000人以上
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中外合资(合资·合作)
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浦东科苑路88号上海德国中心2幢501-533室