Management of QA affairs
QA 日常业务的处理 - Handling, investigation and assessing of quality issues
- Establish, execute and track CAPA
- Review batch production report
- To be involved in regulatory inspections and self-inspection
- Ensure to fulfill the KPIs of QA
- Identify the quality risk during daily work, improve continuously.
- Support PET business processes regarding compliance and quality
- Communicate with other AZ sites regarding to quality issues
- Ensure all the warehousing and distribution activities comply with the GXP requirement.
- Facilitate local vendor management and give support to GES/GDMS group
Additional requirement for Authorized Release QA Engineer
- Release RM, GF and CMO products
- To maintain a smooth product release procedure
- When take charge of the docs/samples archivist role:
Ensure each team can follow document/sample archiving rooms’ procedures to conduct any archiving activities
Ensure each team record all the activities and keep the proper track of docs/samples
Quality system management
质量体系管理 - Draft, review and approve document to make sure in compliance with GMP requirement
- Annual product review
- Own QA procedure, secure operation GMP compliance
- Lead and execute Change Control
- Quality continuous improvement
人员管理 - Provide Coaching for peer and team member to handle QA affairs
安全环境健康责任 - Identify and understand the SHE risk factors within the department
- Develop and carry out plans to address the key SHE issues in the associated areas and ensure the follow up actions are carried out.
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.