職位描述
Responsibilities: * 為項(xiàng)目和工廠提供質(zhì)量專業(yè)知識(shí)支持。 * 協(xié)助 GPQS、ECMS、GVLMS 數(shù)據(jù)庫(kù)的開(kāi)發(fā)并提供專業(yè)知識(shí)。 * 支持和推動(dòng)必要的部門流程、文檔和培訓(xùn)。 * 支持和維護(hù)技術(shù)能力，并與工程、IT、QA、制造和技術(shù)職能部門的同行合作，在指定的項(xiàng)目和活動(dòng)中提供質(zhì)量監(jiān)督。 * 支持 GMP 相關(guān)設(shè)施和設(shè)備系統(tǒng)的質(zhì)量控制工作，以確保完全符合 GMP。 * 嚴(yán)格執(zhí)行崗位操作規(guī)程和指南，完成日常實(shí)驗(yàn)。 * 參加GMP培訓(xùn)，嚴(yán)格遵守GMP與法規(guī)要求 * 發(fā)展各種工作技能并追求持續(xù)的改進(jìn) * 根據(jù)業(yè)務(wù)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(xué)士學(xué)位，并具備藥品質(zhì)量、制造、技術(shù)的一般經(jīng)驗(yàn)。 * 具備 cGMP 和全球 GMP 要求、質(zhì)量體系以及藥品/設(shè)備測(cè)試技術(shù)和藥典的基本知識(shí)。 * 具備計(jì)算機(jī)驗(yàn)證和21 CFR 11的基本知識(shí)。 * 具備良好的人際交往和解決問(wèn)題的能力。 * 具備獨(dú)立和協(xié)作處理多學(xué)科和多功能工作的能力。 * 使用中文和英文作為工作語(yǔ)言。 * 具備出色的口頭和書(shū)面溝通能力，能夠與組織各個(gè)級(jí)別的人員進(jìn)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.
