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Quality Business Partner

Location Wuxi, Jiangsu, China Job ID R-065814 Date posted 11/13/2019

Responsibilities:

  • Provide coordination and oversight of functional quality & compliance
  • Partnering in IMTs
  • Encourage function ownership of Quality
  • Sustain standard process for each PQS across site
  • Conduct Regulations and AZ global QCM compliance Evaluation
  • Agree PQS/GMP improvement priorities
  • Lead regulatory inspection preparations
  • Lead and coordinate Quality key systems in place and improvement, including, but not limited, GMP training GMP, Document management, QAA management, CAPA address, feedback and follow up, Change control, Quality risk management, Self-inspection
  • 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.
  • Provide Coaching for peer and team member to handle QA affairs
  • Compliance with AZ code of conduct and SHE requirement

Requirements:

  • University graduate, major in pharmaceutical or related subjects
  • 8 years plus experience as quality assurance
  • Cross Function working experience
  • Solid GMP and quality system management knowledge
  • Expert of quality management system and key process
  • Capability of identifying quality & compliance deficiency and driving improvement
  • Knowledge of process control methodology and statistics, for example Cpk, FMEA
  • Working knowledge of Microsoft applications, SAP or similar system
  • Good English
  • Good Computer skill
  • Good communication and transversally cooperation, team leading capability
  • 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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Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.