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Manager-QC

Location Shanghai Downtown, Shanghai Municipality, China Job ID R-066006 Date posted 11/17/2019

Lead Continuous Improvement In Quality of China MA led Clinical Studies
•Lead the development and execution of
annual study/PV system QC plan which is
agreed with TAMD and EvGen AD and
PV leader
•During QC, provides in-the-moment
feedback and coaching to relevant MA
staff and study site staff. Provide
closing feedback to all staff involved
•Ensure China MA is ready for audit and
inspection at any time
•Provide advice on Corrective actions and
preventive actions (CAPA) for QC/audit/
inspection findings
•Conduct root cause analysis on all
significant QC/audit/inspection findings
and work with study/PV team leader
to share learning across relevant
study/PV team and work to avoid
recurring issues
•Identify opportunities for quality
improvement and optimizing/simplifying
relevant processes
 Significant and general audit/ inspection findings reduces year on year
Ensure Responsible Procedures Documents for Clinical Studies concise and readable, and complying GCP, AZ SOPs and relevant Chinese regulations
•Contribute to development, maintenance
and improvement responsible procedural
documents of China MA for clinical
studies/PV
•Drive the development, implementation
and maintenance of responsible local
procedural documents for clinical
studies/PV only if the Global or Regional
procedural documents cannot adequately
address the requirements in China
• Provide advice on clinical study/PV
procedures to authors of local procedural
documents
 Any local procedural document developed is concise and readable, in compliance with ICH GCP, China GCP, AZ global/regional procedures and relevant China regulations
 Timely notification to China MA study teams if any update in responsible procedural documents
 Study teams receive advice on study procedures as needed
Training
• Deliver trainings for study/PV teams which
are to emphasize the procedural key points or the update of global\local procedures
• Organize learning from QC checking, Audit and inspection for study/PV teams which is aimed at increasing study/PV team capability to deliver qualified study/PV activities
 Significant and general audit/inspection findings reduces year on year
 Trainings are organized to meet study team needs in driving quality objectives



AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

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  • Clinical Development, Shanghai Downtown, Shanghai Municipality, ChinaRemove

Glassdoor logo Rated four stars on Glassdoor

Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.