Sr.QA Engineer

Typical Accountabilities:

• Maintain the QMS of China MCOQ to ensure the compliance to AstraZeneca QCM &standards and GSP regulations regarding to China trading companies.
• Serve as quality liaison to the drug regulatory agency (if required), support GMP&GDP audits and inspections, and support the smooth closure of inspections.
• Ensures effective and timely product quality and security complaint management by China markets.
• Create the links between China MCOQ and business stakeholders like commercial teams, CDC, supply chain, IT, ITQM, Business Units, Marketing, legal, PR, China Patient Safety, Operation Sites etc. in terms of quality management and optimization.
• Identify the quality and compliance gap and work out improvement plan with area manager.
• Contributes to development procedures in area of specialism and provides some technical input into the development of global standards for function and globally.
• Leads trouble shooting activities to resolve existing problems, make complicated judgements
• Drive the quality process improvement and simplification as quality business process champion, ensuring GMP/GDP/GSP compliance and AZ global standard compliance.
• Identify and understand the SHE risk factors within the department.

Requirments:

• Bachelor’s degree or above, majored in a science/technical field such as Pharmacy, Biology, Chemistry, licensed pharmacist is preferred.
• 5+ years prior experience in GMP/GSP/GDP and compliance management environment.
• 3+ years’ experience of supplier quality management and distribution quality management.
• Experience of working cross functionally across the supply chain with groups such as regulatory affairs, manufacturing, supply and account management, etc.
• Solid GMP/GSP/GDP  and quality system management knowledge, and pharmaceutical knowledge.
• Good problem solving ability, especially leading to solve the quality-related problems.
• Good English.

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.