• China
  • Save Job
  • 5 - 8 Years
  • Posted : above 1 month

Job Description:

Job requirements /

Academic / Professional qualification / /

Bachelor degree in medical or pharmaceutical sciences required

Technical / skill training / /

Knowledge in medical affairs activities/ GCP/ GVP

Working experience (No of years / , Job function / , Business types / )

At least > 5 years multinational pharmaceutical company working experience

Fluent in Mandarin and English

Good at office


1 Ensure MA activities in compliance

Regular review on compliance procedures, MA related procedures and management platforms with the aim of continuous improvement in the quality of MA activities
Set a system of regular self-checking with timely completion of corrective actions
Develop annual QA plan which is agreed by MA leadership team
Execute event/project and system QA according to the annual QA plan
Regular review on the cross-function Quality Control status in MA and provide periodic reports to MA leadership team on compliance status
Provide recommendation to Medical QC Manager for root cause analysis and contingency/remedy plan
Initiate risk management process in MA
Develop, maintain and document the processes and procedural documents on MA ownership according to global and local procedures
Organize the trainings as the owner of all MA SOPs and guidance
Coaching QC mgr on quality management
Organize case sharing and feedback learning
Contact person for global audit and local inspection (non-GVP, non-GCP)
Organize medical affairs internal mock audit

Significant and general audit findings and QA findings reduces year on year
Compliance with local legislation, codes of Conduct/Practice and AstraZeneca internal standards as measured by internal quality checking and audits of materials and activities
Feedback from QC personnel, line manager and MA leadership team
Feedback from presentation/ training sessions

2 Ensure effective operational implementation of the QMS across all GxP areas in AZ China

Organize monthly cross GxP QMS meeting
Proactively communicating compliance trends and risks to the GxP Country Quality Lead
Provide and/or coordinate the required trainings in the GxP area
Coordinate GxP self-assessments performed internally by the MC personnel to ensure adherence to procedures and standards
Monitoring all relevant KPIs They include global KPIs already established and communicated regularly by the global functions but also local KPIs (defined in the MC, based on risks and improvement areas)

AZ China GxP Quality Manual is up to date
Self-assessment is conducted per annual plan
CIPs is fully implemented
Feedback from GxP Quality Leads


Skill and Job requirements

Understanding of the working scope of the functions in Medical Affairs
Sound knowledge of international and RDPAC medical compliance legislation, codes of practice and their practical application
Knowledge and experience of corporate governance are desirable

High ethical standards An understanding of ethical decision making processes and an ability to discuss ethical and regulatory issues with credibility and authority
Strong strategic thinking, independence and analytical skills
Excellent communication and presentation skills
Good interpersonal, influencing, networking and coaching skills, to interact effectively across different functions, seniority levels and cultures within the Company and externally

Leadership Capability

Functional capabilities

Sets high ambitions and demands excellence from team
Set up consistent high performing team over time
Consistently improving all team members performance
Able to advise and coach other managers on their coaching skills
Proactively support career opportunities mapping for high performers

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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Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Biotechnology/Pharmaceutical/Medicine, Manufacturing/Industrial
Functional Area : Doctors/Nurses/Medical Professional
Role : Other Medical
Salary : As per Industry Standards
Deadline : 14th Jul 2020

Key Skills:

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