QMS专家
面议
预约职位
工作性质全职
职位类别其他职位
招聘人数1人
学历要求本科
工作经验5-10年
性别要求
用工形式不限
技能等级
年龄要求不限
试用期
工作地点江苏省/泰州市
职位描述
岗位职责 1. Participate in the establishment, operation and improvement of GMP systems of the company. 参与公司 GMP 质量体系的建立、运行及完善 2. Responsible for obtaining all kinds of drug management and related laws, regulations and technical requirements, and archive management and notification management 负责获得各类药品管理及相关法律、法规和技术要求,并作归档管理和通报管理 3. Participate in complain, self-inspection of quality management system to ensure its effective operation 参与质量管理体系自检、投诉等,确保其有效运行 4. Preparation, review, revision and management of GMP documents of the department including SOPs, Protocols, reports, investigation, Etc 参与本部门 GMP 文件的编制、审核、修订和管理工作 5. Responsible for reviewing SOP prepared by each department 负责审核各部门起草的 SOP 6. Responsible for perform investigations, ****uations and management of quality notifications such as deviation, CAPA, Market compliments, FAR, OOS/OOT change controls etc 负责事件调查及评估,偏差, CAPA ,市场投诉, FRA,OOS/OOT 等等相关质量的管理 7. Participate in preparing, reviewing and revising Specification, Standard Test Procedures and General Test Procedures 参与质量标准、标准检验规程、通用检验规程的起草、审核和修订 8. Participate in validation and qualification related work, such as preparing protocol and reports, implementation and monitoring of plans, etc. 参与验证与确认相关工作,比如方案和报告的起草、方案的实施和跟踪等 9. Responsible for Supplier/Vendor qualification. Supplier site audits where required. 负责供应商资质确认 10. Responsible for retention samples management, including daily management of retention samples room 负责留样管理,包括留样间的日常管理 11. Responsible for the check of laboratory test data 负责实验室检测数据的审核 任职要求 1. Bachelor degree or above, major in pharmacy or related 本科及以上学历,药学或相关专业 2. Good command on English in listening, speaking, reading and writing, English can be used as working language 英语听、说、读、写能力强,英语可以作为工作语言 3. At least 8 years working experience in pharmaceutical industry; at least 5 years QA team management experience, GMP certification, familiar with GMP related specifications; familiar with FDA certification management skills is preferred 8年以上制药行业相关工作经验 ; 5 年以上 QA 团队管理经验,参加过 GMP 认证,熟悉 GMP 相关规范;熟悉 FDA 认证相关管理技能者优先 4. Have a strong sense of responsibility and team spirit, good interpersonal communication, coordination and communication skills 有较强的责任心和团队精神、良好的人际沟通、协调和交往能力
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