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PV QC Manager

Location Shanghai Downtown, Shanghai Municipality, China Job ID R-105136 Date posted 21/04/2021
  • Job Summary

  • Provides support and advice on process technology vision and strategy as an expert or through the supervision of a local team. Recognised expert in own field and often first point of contact for related queries. Will provide analysis and trending of data or collaborate with stakeholders to identify trends through project management. Will develop and maintain Patient Safety Enablement  process and technology vision and strategy in support of the global owners.

  • 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

  • • Qualified to apply for China Merchants Bank Credit Card (Business expenses should be reimbursed through company credit card)

  • 具备入职后能办理招商银行信用卡的资格(通过报销的业务消费必须使用公司商务信用卡)

  • AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.

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.

50056662 E CDPB International

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Glassdoor logo Rated four stars on Glassdoor

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