Tiffany Gan

About Tiffany Gan

Quality engineering SME and leader in agency regulated pharmaceutical and medical device industry with extensive experience in both development and manufacturing. Experience covers multiple dosage forms including oral solid, parental, topical, MDI, and combination product. Experienced lead investigator and final QA approver for non-conformance and manufacturing events investigation, auditor. CAPA management, compliance overview and process improvement in multinational setting.

Experience

1. Staff Quality Engineer Rac Asq-cqe Cqa

   BD

   Jan 2022 — Present · US

   Design Assurance – Class II Medical Device and Dispensing portfolioR & D Quality EngineeringSustaining engineering Verification and Validation Labeling Verification Design transferRisk based Quality Management System Quality system gaps mitigation (Complaint data, supplier review, CAPA and deviation)Cross functional team coaching and development Operation Quality EngineeringDesign change and product optimizationEnd of life component updateDesign verification and validation ISO 13485/14971:2019/21CFR820/MDR 2017/745IEC 60601/62304/62366

Education

• East Carolina University

  Master of Science (M.S.), Analytical Chemistry

Skills

• Manufacturing
• Quality Assurance
• Lims
• Change Control
• Cross-Functional Team Leadership
• Iso 13485
• Trackwise
• Gxp
• Quality Auditing
• Sop
• Fda
• Validation
• 21 Cfr Part 11
• Process Improvement
• Capa
• Internal Audit
• Gmp
• Laboratory
• Analysis
• Quality System
• V&V
• Asq Cqa
• Glp