药品质量体系高级专员
- 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
- Document management
- QAA management
- CAPA address, feedback and follow up
- Change control
- Quality risk management
- Self-inspection
- Complaint Management
- KPI data collection and reporting to global
- 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.
- Lead localization of global QCM to ensure comply with corporate quality
- Lead intelligence of external regulation, provide compliance advise when necessary
- Provide support on change management of QA E-system, eg. SAP, AZDoc, OCM, IDM， GCM etc.
- SAP, AZDoc, OCM, IDM, GCM等
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.
