Lead /Principal Engineer, Packaging Process

文件

• Author technical related SOP, WI, BRP, EBR, Technical Reports, Validation documents, etc., ensure master data is accurate.

撰写技术相关的SOP,WI, 批记录、电子批记录、技术报告、验证文件等;确保主数据维护的准确

• Author technical training materials and manage product knowledge

撰写技术培训材料,并管理产品知识。

项目管理

• Lead or support technical project deliverables on time in full, and compliance with AZ PMF, e.g., CMC variation, TT and continuous improvement.

按照AZ PMF 的要求,领导或支持技术项目的交付,比如CMC variation, 技术转移、持续改进项目等等。

• Compliance with AZ code of conduct and SHE requirement.

符合公司的行为规范和SHE的要求

Technical Layout and Artwork Management (Apply to Packaging Engineer)

技术图纸以及包装设计管理(适用于包装工艺工程师)

• Maintain the current technical layout and create the new technical layouts for new products.

维护现有的技术图纸,为新产品创建新的技术图纸。

• Ensure the Gazelle system works well in Wuxi site

确保Gazelle系统在无锡正常运行。

• Issue the specification for the new materials/components

制定新材料的质量标准

MBR author

主批报记录撰写人

• Update GMBR, create and update PVL/PMBR

更新GMBR,创建和更新PVL/PMBR

• Deliver different level training to Wuxi site operators as required.

按照需要对无锡工厂的操作员工进行不同程度的培训。

• Handle any PAS-X system technical issues during BAU phase.

在BAU阶段解决PAS-X系统的技术问题。

Education, Qualifications, Experience and Capabilities 教育、资质、经验和能力

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

• 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

• 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

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;

• Analytical method and specification;

分析方法和质量标准;

• CMC and Regulation;

• 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。

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.