该职位来源于猎聘 此职位为项目合同,有意者面聊 Oversee and perform C&Q activities on workstream systems in line with custom requirements.
根据客户需求监督并执行工作流系统的C&Q活动 Support project Commissioning Lead and Qualification Lead on C&Q activities relating to workstream systems assigned. 为项目调试导联和验证导联提供支持,完成所分配工作流系统相关 C&Q工作 Work with CSV workstream for OT qualification needs on systems assigned 与CSV工艺协作,满足所分配系统的OT验证需求 Technical support to the receiving Custom organisation to ensure that specified performance criteria are met during start-up and early operation. 向接收方客户组织提供技术支持,确保在启动和早期运行阶段达到规定的性能标准 Pharma industry C&Q good practices
制药行业调试与验证优良实践 Sound experience on GAMP approach for OT systems
在运营技术系统方面具备GAMP方法的扎实经验 Key Responsibilities
Familiar and ensure custom C&Q guidance are properly implemented 熟悉并确保定制化调试与确认(C&Q)指南得到正确实施 Provide early technical support to system design from C&Q aspect (URS and specification achievable and testable). 从C&Q角度为系统设计提供前期技术支持(确保用户需求说明和规范可达成且可验证) Responsible for preparation/execution/compiling of C&Q activities protocols/reports. 负责C&Q活动方案/报告的编制、执行及汇总工作 Responsible for contractor qualification plan/schedule preparation to meet project needs 负责承包商资质计划/进度安排以满足项目需求 Responsible for URS/Specification review/updating to driving consistent testable statements 负责用户需求说明/规范的审核与更新,确保形成可验证的一致性表述 Support project qualification planning & scheduling throughout project lifecycle; 支持整个项目生命周期的验证规划与进度安排; Support contractor qualification engineer training governance 支持承包商验证工程师培训管理 Support project qualification resource planning and daily arrangement 支持经验教训的审查与实施,维护项目周期内的经验教训日志 Support project to maintain qualification fragnet data for resource, duration and linkage to C&Q strategy 支持项目维护验证分项数据(包括资源、时限及与C&Q策略的关联) Support in project initiatives to reduce capital spend on qualification with GERE projects 支持通过项目举措减少GERE项目的验证资本支出
Support GVLMS entity/event activities 支持GVLMS实体/事件活动 Coordination with different package design engineers, users, contractors to enable timely Right First Time Documents preparations, execution and compliance of C&Q deliverable. 协调不同包设计工程师、用户及承包商,确保"一次做对"文件准备、执行及C&Q交付物的合规性 Preparation of qualification summary reports and management of RTM
编制验证总结报告并管理需求跟踪矩阵(RTM) Attendance at project PDCA and project meetings. 参加项目PDCA会议及项目例会 Support lessons learnt for technical work packages and C&Q management. 支持技术工作包及C&Q管理的经验总结