職位描述
Responsibilities: * 為項目和工廠提供質量專業知識支持。 * 協助 GPQS、ECMS、GVLMS 數據庫的開發并提供專業知識。 * 支持和推動必要的部門流程、文檔和培訓。 * 支持和維護技術能力，并與工程、IT、QA、制造和技術職能部門的同行合作，在指定的項目和活動中提供質量監督。 * 支持 GMP 相關設施和設備系統的質量控制工作，以確保完全符合 GMP。 * 嚴格執行崗位操作規程和指南，完成日常實驗。 * 參加GMP培訓，嚴格遵守GMP與法規要求 * 發展各種工作技能并追求持續的改進 * 根據業務需要完成安排的其他工作 * Provide quality expertise support for the project and the plant. * Support the development of GPQS, ECMS, and GVLMS databases, providing expertise. * Support and drive necessary departmental processes, documentation, and training. * Support and maintain technical capabilities, and collaborate with peers in engineering, IT, QA, manufacturing, and technical functions to provide quality oversight in designated projects and activities. * Support quality control work for GMP-related facilities and equipment systems to ensure full compliance with GMP. * Follow job operating procedures and guidelines to complete daily experiments. * Participate in GMP training and strictly comply with GMP and regulatory requirements. * Develop various work skills and pursue continuous improvement.Requirements: * 擁有學士學位，并具備藥品質量、制造、技術的一般經驗。 * 具備 cGMP 和全球 GMP 要求、質量體系以及藥品/設備測試技術和藥典的基本知識。 * 具備計算機驗證和21 CFR 11的基本知識。 * 具備良好的人際交往和解決問題的能力。 * 具備獨立和協作處理多學科和多功能工作的能力。 * 使用中文和英文作為工作語言。 * 具備出色的口頭和書面溝通能力，能夠與組織各個級別的人員進行有效溝通。 * Bachelor’s degree and general experience in pharmaceutical quality, manufacturing, or technical roles. * A basic knowledge of cGMPs and global GMP requirements, quality systems, and pharmaceutical product/device testing technology and pharmacopeia. Well -developed interpersonal and problem-solving skills. * A basic knowledge of computer validation * Demonstrated ability to work independently and collaboratively on multidisciplinary and multifunctional. * Use both Chinese and English as working language. * Excellent oral and written communication skills with the ability to communicate effectively with individuals from all levels of the organization.
