招聘人数:1 人
性别要求:不限性别
工作职责:Responsibilities Responsible for drafting & delivering validation deliverables (URS, validation plan, risk analysis, design qualification, IQ/OQ/PQ protocol and reports) for main process equipment and GMP facility & utility systems based on validation procedures and templates and to fulfil the overall the project timeline (OSD and Aseptic drug).根据验证程序和模板,负责起草和交付主要工艺设备和GMP设施及公用事业系统的验证交付物(URS、验证计划、风险分析、设计确认、IQ/OQ/PQ协议和报告),并完成整个项目时间表(OSD和无菌药品)。Responsible for review and supervision of supplier s FAT/commissioning/SAT test protocol, execution and final report for GMP systems.负责审核和监督供应商的FAT/调试/SAT测试计划,执行和最终报告GMP系统。Responsible to identify the possible GMP gaps and risks during qualification procedure to minimize the potential risk of regulatory violations.负责在认证过程中识别可能存在的GMP缺陷和风险,以最小化违反法规的潜在风险。Responsible for maintain and periodic review of the validated status for GMP systems after completion of the initial validation works.在初始验证工作完成后,负责维护和定期检查GMP系统的验证状态。Plan and conduct the revalidation activities based on cGMP and internal procedure.根据cGMP和内部程序计划和实施再验证活动。Responsible for the coordination of the risk analysis, protocol/report review and also the coordination of the C&Q test executions.负责风险分析、方案/报告评审的协调,以及C&Q测试执行的协调。Provide professional advises and suggestions to the team from qualification and GMP/quality point of view, keep good communication with project team and realise a transparency information exchange during project phases.从资质和GMP/质量的角度为团队提供专业的建议和建议,与项目团队保持良好的沟通,在项目阶段实现透明的信息交流。Work closely with QA team and other professionals to ensure company s high standards quality system.与QA团队和其他专业人员紧密合作,确保公司高标准的质量体系。Work together with QA team for upcoming corporate audit, client audit as well as regulatory audit.与QA团队一起进行公司审计、客户审计以及监管审计。任职资格:Bachelor degree in Engineering, Pharmaceutical, Chemistry Qualification & validation experiences for process equipment, facility & utility and computerized system (OSD and Aseptic drug).本科学历,工程、制药、化学等相关专业,有工艺设备、设施、公用设施和计算机系统(OSD和无菌药品)的认证和验证经验。Good capability of written English is a must, good oral English is a plus Good knowledge and understanding of cGMP (EMA, FDA, CFDA) regulation Minimum 3 years Work Capability Good team player, work independently and flexible, and ability in planning, organization of qualification/validation activities3年以上cGMP (EMA, FDA, CFDA)法规的知识和理解能力。良好的团队合作精神,独立工作,灵活,有能力策划、组织资格/验证活动
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