周先生
8小时前在线
已认证
- 职位介绍
- 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
- 其他信息
- 行业要求：全部行业
公司简介
朗博斯特自动化是美国制药数字化咨询和专业服务提供商，我们在全球范围内给制药企业提供服务。100%致力于在生命科学数字化领域提供价值服务，特别是专业服务和高端咨询。
朗博斯特自动化亚太区总部位于新加坡，中国公司位于上海浦东陆家嘴。在印尼雅加达有分公司。我们拥有一流的工程团队，并已经给世界顶级制药客户提供了优质服务，例如：礼来，杨森，科赴，罗氏，辉瑞，通用，龙沙，葛兰素史克，阿斯利康等。
主要业务：
咨询服务：数字化工厂整体规划；数字化、信息化整体设计；单个系统设计，数据分析等;
专业服务：项目管理；主题专家(自动化经理，专业工程师)；运营支持和优化；现场服务等；
培训：数字化工厂整体规划培训；计算机验证培训；工艺自动化培训等;
系统集成：制造执行系统，过程控制系统，全厂数据库系统；IT主干网等;
调试验证：计算机验证；CSV体系建设；C&Q支持等;
查看全部
猎聘温馨提示：
- 1. 如您发现平台内招聘方存在以下违规行为的，请立即举报
-
- · 扣押您的身份证件或者其他证件；
- · 要求您提供担保人、担保金或者以其他名义向您收取财物（ 如培训费、体检费、资料费、置装费、押金等）；
- · 强迫您入股或者向您集资；
- · 以招聘名义牟取不正当利益；
- · 发布虚假招聘广告信息；
- · 工作时长违反劳动法规定；
- · 存在其他损害您的合法权益的行为。
- 2. 如您应聘的岗位属于涉外劳务合作/海外岗位的，请务必核实招聘方对外劳务合作资质取得情况，同时注意自身资金安全，防范招聘欺诈。
- 了解更多安全防范知识>
- 3. 本平台招聘方不向求职者提供任何收费服务。
猜你喜欢
张先生
招聘主任/人才招聘高级经理
陈女士
薪酬绩效主管
王女士
人力资源经理
王女士
人事专员
潘女士
HRBP
王女士
人事主管
李女士
人事
刘先生
人力资源主管
王女士
招聘专员
1
2
3
4