QA - Assistant Specialist

SHL (Scandinavian Health Ltd) is currently the world's largest privately-owned designer, developer and manufacturer of advanced drug delivery systems. The organization was established in 1989 by Swedish entrepreneurs Roger Samuelsson and Martin Jelf with the goal of combining world-class manufacturing in Asia with the strengths of Western Management practices. SHL manufactures devices including pen injectors, auto injectors and inhaler systems. We also manufacture a range of other products including pressure mattress systems, patient lifting slings, medical soft goods, beds, neurosurgical devices, catheters and industrial equipment.

瑞健集團(SHL)成立於1989年，目標以西方管理模式在亞洲打造具有國際水準的生產中心。如今，在全球製藥及生物科技領域，SHL已成為藥物輸送系統的OEM/ODM領導製造商，如自動安全注射器。除此之外，SHL還擴展許多產品線，像是軟性結構類醫療產品、醫療氣墊床、醫療床、腦神經手術器具、工業 設備和醫療用吊昇設備等，目標市場為北美、歐洲及亞洲。

【Job Overview】

The assistant specialist will work with Quality Assurance to assist the compliance activities of developing and manufacturing processes. Complete duties assigned by supervisor, such as handling records/ documents, training new staffs, supporting continuous improvement projects, implementing quality control standards, and adhering to legislation requirements.  
此助理專員將與品質保證部門合作，協助開發和製造過程中的合規活動。完成主管指派的工作，例如處理記錄/文件、培訓新員工、支援持續改進項目、實施品質控制標準，並遵守相關法規要求。

【Responsibilities】

• Review data, validation protocols/documents, manufacturing records, specifications, and manufacturing documents for compliance.
• Develop and maintain standards for inspection
• Ensure the compliance of product manufacturing and product release processes
• Support processes to streamline and implement the new system as needed.
• Create/ Maintain SOPs as needed.
• Follow GMP guidance and adhere to SOPs and GMP requirements.
• 審查數據、驗證協議/文件、製造記錄、規格和製造文件，確保其符合規範。
• 制定並維護檢驗標準。
• 確保產品製造和產品放行過程的合規性。
• 支援流程以簡化並根據需要實施新系統。
• 根據需要創建/維護標準作業程序（SOP）。
• 遵循良好製造規範（GMP）指導並遵守 SOP 和 GMP 要求。

【Qualification】

• Ability to communicate appropriately and accurately both orally and in writing the progress of assignments
• Able to work on documentation processing & data reviewing.
• Proactive, eager to learn new things, and has good communication skills in both English and Mandarin
• Proficiency in Microsoft Office Programs
• <1 year experience in a regulated environment (GMP) is preferred.
• <1 year experience in Quality Assurance is preferred.
• 能夠適當且準確地以口頭和書面方式溝通工作進度。
• 能夠處理文檔處理和數據審查工作。
• 積極主動，渴望學習新知，並具備良好的英語和中文溝通能力。
• 精通 Microsoft Office 軟體。
• 具有 <1 年的受規範環境（GMP）經驗者優先。
• 具有 <1 年品質保證領域經驗者優先。