Lead Principal Engineer, Packaging Process

Typical Accountabilities

主要职责

Qualification and Validation

确认和验证

• To update SVMP and ensure the visibility of validation plan execution status across the site;
• 更新工厂验证主计划确保其执行状态的可见性
• To coordinate with the site QSR implementation;
• 协调工厂QSR的实施
• To give the training on the validation concept and local validation document requirement as requested;
• 根据要求对工厂验证概念和验证文件进行培训
• To draft VMP/VP as appropriate;
• 起草验证主计划/计划如适用
• To review and approve the validation doc as appropriate;
• 审核和批准验证文件如适用
• Be as the validation representative to facilitate the validation work across the project;
• 作为验证代表推进整个项目的验证工作
• Be as the validation representative to do the validation assessment for each change control via risk-based approach;
• 作为验证代表对每个变更控制在考虑风险的基础上进行验证评估
• To generate/maintain the validation Doc template for each type of validation;
• 制定/维护验证模板
• To generate/maintain the validation training package.
• 制定/维护验证培训材料
• Manage qualification and validation related change activities e.g. supply switch over management validation batches release management etc.

管理验证相关的其他活动比如供应切换验证批的放行管理等等

Process Development and Improvement

工艺开发和优化

• Investigate issues encountered during routine production; provide the technical evaluations and studies (e.g. DOE) to drive process robustness.

调查日常生产过程中遇到的问题 进行技术评估和研究(比如实验设计)改进工艺稳健性

• Take product and process ownership to conduct CPV identify improvement opportunities address the risks and take proactive actions.

持续工艺确认 识别风险和机会并采取措施

• Work with internal and external stakeholders e.g. quality supply chain manufacturing M&ST Ops Regulatory China RA etc. to manage technical related affairs such as GCE CMC variation projects etc.

和内外部的利益相关者合作管理技术相关的事物比如仿制药一致性评价CMC的变更项目等

• Act as the process and regulatory experts to coach quality technical and manufacturing team to uplift capabilities.

作为工艺和法规的专家指导技术质量和生产团队的能力提升

• During contract manufacturing conduct onsite supervision of production activities related to AstraZeneca products ensuring compliance with manufacturing processes quality standards and regulatory requirements.

在委托生产期间对阿斯利康产品生产相关活动进行现场监督确保符合生产工艺质量标准等法规要求

Education Qualifications Experience and Capabilities 教育资质经验和能力

Education Qualification Experience

教育资质经验

• University graduate or above

本科学历/以上

• Professionalism in the Pharmaceutical knowledge and experience; including production processes validation trouble shooting investigation and continuous improvement

专业级的制药知识包括生产工艺验证问题解决调查和持续改进

• Knowledge of specific dosage forms.

• Oral Solid Dosage knowledge required for formulation lead process engineer;
• sterile/aseptic process and microbiology knowledge required for sterile lead process engineer;
• Blister & bottle packing etc. knowledge required for packing lead process engineer

相应区域的专业知识

• 包装主管工艺工程师需具备泡罩包装瓶包装西林瓶包装及复合袋包装 等相关知识
• GMP and regulatory knowledge

GMP和法规知识

• Professionalism in process and cleaning validation

精通工艺验证和清洁验证知识

• Excellent written/Oral English

英语书写/口语优秀

• High level of computer skills

精通电脑

• Strong statistical knowledge with experience in DoE limit setting etc.

扎实的统计学知识具备实验设计限度设定等统计学应用经验

• Experience in PM or Technical Supports of CMC variation and TT.

在CMC 变更和技术转移项目上具备项目管理或技术支持的经验

• At least 1-year experience in the areas of GMBR/PVL/PMBR creation and update

在GMBR/PVL/PMBR创建和更新方面拥有至少1年的从业经验

• At least 5 years experience in pharmaceutical process

至少具备5年以上的制药技术工作经验

Capabilities

能力

• Risk Management analysis and problem solving;

风险评估分析和问题解决;

• Project Management;

项目管理;

• Pharmaceutical process with data analysis;

制剂工艺和数据分析;

• Writing Capability;

写作能力;

• GXP and Quality Management;

GXP和质量管理;

• Analytical method and specification;

分析方法和质量标准;

• CMC and Regulation;

CMC和法规;

• Finance evaluation;

财务分析;

• Strong leadership capability in communication coordination influence judgement coach and emotion intelligence.

较强的领导力包括交流协作影响力判断力指导和情绪智商

• At least level 2 of MBR author skill

至少达到主批报记录撰写人的2级技能要求

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds with as wide a range of perspectives as possible and harnessing industry-leading skills. We believe that the more inclusive we are the better our work will be. We welcome and consider applications to join our team from all qualified candidates regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment) as well as work authorization and employment eligibility verification requirements.