岗位职责
Main Tasks & Responsibilities :
1. Ensure all PCR compounding and filling related tasks are in compliance including quality and safety requirements. As the SME of chemical materials, provide technical expertise of handle chemical materials.
2. Assess, and develop new and/or transfer existing filling/compounding technical requirements and SOPs to fit RDSZ needs and ensure that these requirements are defined with clear roles and responsibilities for the operation team of filling/compounding.
3. Build product BOM, master recipe, SOP of the PCR products
4. As technical SME of filling/compounding, engage in optimization on manufacturing process & related equipment system.
5. Responsible for systematic investigation and analysis for common process issues and providing technical solution.
6. In collaboration with respective service provider, supply chain, facility management, equipment maintenance and project teams, lead or support project of manufacturing capacity expansion or efficiency improvement.
7. Working on deviation reports (e.g. out of specification, events, deviations, CAPA-Processes)
8. Coordinate or support on equipment FAT, SAT, IQ/OQ, PQ and process validation. Ensure production equipment, processes are qualified and validated.
9. Assessment and management of product quality data (Trend analysis). Lead or support on triggering correct & preventive action and improvement project for quality compliance and operation optimization.
10. Technical support on the cooperation with the interfaces (e.g. sending site, QC, R&D, international supplier) on product issue solution, decision on action and implementation.
11. Engage in the team build up, induction, training & qualification and development within the department. Work out SOPs and the training materials, technical and production document. Technical training for filling operators.
1. Ensure all PCR compounding and filling related tasks are in compliance including quality and safety requirements. As the SME of chemical materials, provide technical expertise of handle chemical materials.
2. Assess, and develop new and/or transfer existing filling/compounding technical requirements and SOPs to fit RDSZ needs and ensure that these requirements are defined with clear roles and responsibilities for the operation team of filling/compounding.
3. Build product BOM, master recipe, SOP of the PCR products
4. As technical SME of filling/compounding, engage in optimization on manufacturing process & related equipment system.
5. Responsible for systematic investigation and analysis for common process issues and providing technical solution.
6. In collaboration with respective service provider, supply chain, facility management, equipment maintenance and project teams, lead or support project of manufacturing capacity expansion or efficiency improvement.
7. Working on deviation reports (e.g. out of specification, events, deviations, CAPA-Processes)
8. Coordinate or support on equipment FAT, SAT, IQ/OQ, PQ and process validation. Ensure production equipment, processes are qualified and validated.
9. Assessment and management of product quality data (Trend analysis). Lead or support on triggering correct & preventive action and improvement project for quality compliance and operation optimization.
10. Technical support on the cooperation with the interfaces (e.g. sending site, QC, R&D, international supplier) on product issue solution, decision on action and implementation.
11. Engage in the team build up, induction, training & qualification and development within the department. Work out SOPs and the training materials, technical and production document. Technical training for filling operators.
任职要求
Qualification & Experience
Had the education background of Manufacturing, Engineering, Bioengineering/Pharmaceutical Science or equivalent.
> 8 years working experience in a high regulated manufacturing site
Familiar with problem solving methods
> 5 years’ experience in managing and leading technical projects and tasks.
Familiar with NMPA Medical Device Good Manufacturing Practice
Very good spoken and written English is a mandatory requirement
Good at MS Office software as well as basic validation skills
At least 2-3 years’ experience in SAP
Had the education background of Manufacturing, Engineering, Bioengineering/Pharmaceutical Science or equivalent.
> 8 years working experience in a high regulated manufacturing site
Familiar with problem solving methods
> 5 years’ experience in managing and leading technical projects and tasks.
Familiar with NMPA Medical Device Good Manufacturing Practice
Very good spoken and written English is a mandatory requirement
Good at MS Office software as well as basic validation skills
At least 2-3 years’ experience in SAP
公司基本信息
性质：外资企业
行业：制造业
规模：中型（100~299人）
地址：苏州工业园区钟园路259号
公司概况
罗氏诊断产品（苏州）有限公司成立于2015 年4 月，总投资额约6 亿美元（约40亿人民币），位于中国苏州工业园区。作为罗氏诊断全球运营网络在亚太地区建立的首个生产和研发基地，它将为推动罗氏公司在中国及该地区取得快速持续增长奠定坚实基础。
2018年10月，该生产和研发基地正式落成并投入运营，占地面积约75000平米，为中国及亚太地区的实验室和医院持续、稳定地提供百余种高品质生化、免疫以及组织诊断检测试剂，包括关键代谢、心血管、肿瘤和肝脏紊乱以及传染性疾病相关的检测。这些检测在疾病管理方面起着决定性作用，并且有助于我们更好地针对种类繁杂的病症进行诊断和监测工作。同时，该生产和研发基地也为欧洲市场提供多种PCR培养基检测试剂，用于新冠病毒的检测。
罗氏诊断苏州拥有完整的研发、制造产业链，以及仓储、物流等功能。截至目前，公司拥有约700名多技能人才，包括来自多个国家的生产运营和研发高端人才，以及来自罗氏全球的技术精湛、经验丰富的研发科技人才。
未来，罗氏诊断将持续探索更多项目在苏州落地的可能性，并携手各方积极参与医疗创新项目的建设，以及将更多前沿的体外诊断解决方案带入中国，造福中国患者。
2018年10月，该生产和研发基地正式落成并投入运营，占地面积约75000平米，为中国及亚太地区的实验室和医院持续、稳定地提供百余种高品质生化、免疫以及组织诊断检测试剂，包括关键代谢、心血管、肿瘤和肝脏紊乱以及传染性疾病相关的检测。这些检测在疾病管理方面起着决定性作用，并且有助于我们更好地针对种类繁杂的病症进行诊断和监测工作。同时，该生产和研发基地也为欧洲市场提供多种PCR培养基检测试剂，用于新冠病毒的检测。
罗氏诊断苏州拥有完整的研发、制造产业链，以及仓储、物流等功能。截至目前，公司拥有约700名多技能人才，包括来自多个国家的生产运营和研发高端人才，以及来自罗氏全球的技术精湛、经验丰富的研发科技人才。
未来，罗氏诊断将持续探索更多项目在苏州落地的可能性，并携手各方积极参与医疗创新项目的建设，以及将更多前沿的体外诊断解决方案带入中国，造福中国患者。
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