您好，我是黃于玲，目前有12年以上的工讀及工作經驗。
【個人特質】認真、善於傾聽、具有換位思考之能力、勇於挑戰，個性溫和、待人和善。
【工作經驗】櫃台人員、儲備幹部、品管人員、活動人員/場佈/進撤場。
近期有參與/擔任各式活動人員，提升應變能力和活耀靈活度及溝通能力。
醫療器材法規/臨床/品質系統
1. 品質系統與文件建立(ISO13485/QMS/QSR)
2. 國內外醫療器材產品認證註冊申請作業(FDA/TFDA/CE MDR/CE IVDR)
3. 協助建立及審查醫療產品技術文件(軟體確效、生物相容性、滅菌、可行性、資訊安全、風險管理、上市後監督)
4. 管理各國醫療法規與產品適用標準及教育訓練執行
5. 臨床試驗申請規劃與協助執行
6. 相關法規、標準、證照申請資料之蒐集及維護
24歲，現職品管人員，邏輯佳善於溝通與團隊合作，做事謹慎且細心，熱愛學習，面對感興趣的東西能夠快速上手且有熱情。
Experienced and dedicated manufacturing specialist for biological drug in the pharmaceutical industry, with a solid track record of four and a half years in the field. I have gained valuable experience collaborating with multiple departments within the pharmaceutical company, including the Manufacturing Department, Research and Development (R&D) Department, Testing and Inspection Department, Quality Assurance (QA), and Quality Control (QC) Department.
I am a motivated, intelligent, and successful professional with more than 12 years QA experience in pharmaceutical industry (ranging from clinical to commercial products). Experienced at implementing Quality Management Systems. Considerable experience in internal and supplier GxP/ISO/ICH auditing as a qualified lead auditor. Demonstrated ability to create and manage effective teams, and work with different groups at an international level. Able to create strong relationships with colleagues and clients. A motivator and always supportive of the team. Cooperative and hands-on style, results orientated, versatile, persistent and self-motivated.
