Yafan Su
- Role
- Qa Specialist at WuXi Biologics
- Location
- Highland Park, NJ, US
- LinkedIn followers
- 500 followers
About Yafan Su
Total 8 years in pharmaceutical field with 3 years of research experience in proteins…
Experience
Qa Specialist
Jun 2021 — Present
Responsible for raw material and product release. Familiar with SAP. • Assist with cell bank management and cell bank release. • Support MQA for batch record review, issuance and approval. Support room clearance. Provide online support and monitoring for manufacturing to ensure the GDP and production is in compliance. • Training Manager. Organizing and monitoring new employee orientation programs and continuous training to ensure that all GMP personnel are qualified. Collaborate with the department training coordinators for personal qualifications. • MasterControl SME. Providing technical support and MC training for all US site employees. Expert for online documentation and training systems. • Assist with reviewing equipment and instrument IOPQ report • Assist QC for QA for analytical method validation, approving protocols and reviewing testing report. • Assist with external client’s audits, providing documentation support • PD(product development) QA for non-GMP/GLP, including reviewing SOP/protocols/reports as client requirement, assigning document numbers
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