该职位来源于猎聘
此职位为项目合同,有意者面聊 The C&Q Subject Matter Expert is responsible for the following, within her/his area of expertise: C&Q领域专家在其专业范围内需履行以下职责: Technical direction and leadership to ensure the appropriate C&Q activities are performed in line with requirements. 为确保持证与确认活动符合要求提供技术指导和领导力 Technical governance to the project delivery organisation throughout the project lifecycle.
在项目全生命周期中对项目交付组织进行技术治理 Technical support to the receiving Custom organisation to ensure that specified performance criteria are met during start-up and early operation.
为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 In addition to governing the design, specification, and commissioning & qualification of the packages within their remit, SMEs will consciously also own and champion the overall Operational Lifecycle within their specialist areas e.g. 除管辖范围内设备包的设计、规格制定及调试确认工作外,领域专家还应主动承担并推动其专业领域的全运营生命周期管理,例如:Pharma industry C&Q good practices 制药行业C&Q良好实践 C&Q on facilities and utilities 设施与公用工程的C&Q工作 C&Q on process equipment and packing equipment relating to tablet manufacturing and packing process
涉及片剂生产和包装工艺的流程设备及包装设备的C&Q Sound experience on GAMP approach for OT systems
对OT系统采用GAMP方法具有扎实经验 Key Responsibilities
Provide early technical support to system design. 为系统设计提供早期技术支持 Familiar and ensure Custom C&Q guidance are properly implemented 熟悉并确保定制化C&Q指南在以下环节得到正确实施 Lead in C&Q engineer training, as required 按要求在C&Q工程师培训中实施导联 Lead in C&Q contractor training, as required 按要求在C&Q承包商培训中实施导联 Ensure key Custom GMP compliance requirements are reflected in the C&Q deliverables 确保关键定制化GMP合规要求体现在C&Q交付成果中 Review the GMP Compliance Tracker topics to ensure all C&Q standards are being complied with. 审核GMP合规追踪表主题,确保所有C&Q标准得到遵守 Engage with key Custom stakeholders to ensure that their needs are understood and reflected in the C&Q activities 与关键方沟通,确保其需求被理解并执行在C&Q工作 Work closely with C&Q Contractor and C&Q Engineers to develop the protocols, lead the translation of Custom needs into C&Q requirements. 与C&Q承包商和C&Q工程师密切合作制定方案,将定制化需求导联转化为C&Q要求 Participate in and make recommendations for the C&Q strategy for system commissioning and qualification 参与系统调试和确认的C&Q策略制定并提出建议. Champion the timely engagement, review and approval of C&Q protocols/reports with Customer team. 推动客户团队及时参与、审核和批准C&Q方案/报告 Technical guidance and coaching to WPO teams within their areas of responsibility. 为WPO团队在其责任范围内提供技术指导和培训 Ensure specific technical solutions/recommendations are consistent with Customer, cost and schedule requirements. 确保具体技术解决方案/建议符合客户要求、成本及进度要求 Provide technical support to system Commissioning and Qualification activities. 为系统调试和确认活动提供技术支持
Review and approve FATs, SATs, DQ, IQ and OQ protocols for GMP and critical GEP systems (as required). 审核并批准GMP和关键GEP系统的FAT、SAT、DQ、IQ和OQ方案(按要求) Attend relevant pre-FATs, FATs, mechanical completion inspections & SATs to assure completeness and correctness of equipment packages. 参加相关预FAT、FAT、机械完工检查及SAT,确保设备包的完整性和正确性 Provide technical approval to commence commissioning and qualification activities, in line with CPDP Assurance stage-gate process. 根据CPDP保证阶段流程,提供开展调试和确认活动的技术批准 Provide Custom technical best-practice advice to work package teams to support development of delivery strategies. 为工作包团队提供定制化技术最佳实践建议,支持交付策略制定 Provide tactical advice and direction to resolve technical difficulties during C&Q execution. 在C&Q执行期间提供解决技术难题的策略性建议和指导 Provide technical approval for critical packages to commence commissioning and then commence qualification activities.
为关键设备包提供开展调试和确认活动的技术批准 Support lessons learnt for technical work packages and C&Q management. 支持技术工作包和C&Q管理的经验总结