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Compliance Specialist

Plats Wuxi, Jiangsu Sheng, Kina Jobb-id R-056916 Datum inlagd 07/26/2019

Job Responsibilities:

-Coordinate Quality key systems in place and improvement, including, but not limited,

•GMP training

•Document management

•QAA management

•CAPA address, feedback and follow up

•Change control

•Quality risk management


-KPI data collection and reporting to global KPI

-Quality performance review and reporting

-Continuous improving on quality and compliance

-Coordinate and lead GMP inspection from external heath authorities

-Coordinate the communication with local healthy authority

-Coordinate Site registration in China market.

-Support CMCRC for site registration and product registration in global markets. 

-Support China RA for product registration in China market.

-Support China Tendering team for entrusted inspection in China market.

-Provide support and administration on QA E-system, eg. SAP, AZDoc, OCM, IDM etc.

-Compliance with AZ code of conduct and SHE requirement.

Job Requirements:

  • University graduate, major in pharmaceutical or related subjects
  • 3-5 years  experience as quality assurance
  • Good GMP and quality system management knowledge
  • Knowledge of product process and typical equipment
  • Working knowledge of Microsoft applications, SAP or similar system
  • Good English
  • Good Computer skill
  • Good communication skills, proactive leadership, strong quality minds and strong service minds     

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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