Product transfer Engineer产品转移工程师
纽迪希亚制药(无锡)有限公司
- 公司性质:外资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2013-07-12
- 工作地点:无锡
- 招聘人数:1
- 工作经验:二年以上
- 学历要求:本科
- 语言要求:英语精通
- 职位类别:生物工程/生物制药
职位描述
主要职责:
Responsible for pilot line & lab’s system maintain and improvement. Implement the pilot trial’s proposal, to review and manage the output. Responsible for new products and new ingredients’ transfer to production line.负责研发实验室的体系维护及改进。研发试验的方案实现, 总结及管理。负责研发新产品、新原料等向生产转移的技术工作。
1、Be accountable for the environment ,hygiene safety and quality issues in position as well as subordinates (if available) 对本岗位职责范围内的环境卫生安全和质量负责,并对下属(如果有)的工作质量和环境安全负有责任。
2、Maintain and implement the best, surest and easiest work processes. Initiate, participate and facilitate the continuous improvement activities on safety, quality, cost, delivery, motivation and environment by applying DaMaWay (including LEAN principles etc). 维护并实施最好、最可靠、最简单的工作流程;应用DaMaWay(包括精益原理等),在安全、质量、成本、交付、激励和环境方面,发起、参与并推动持续改进活动。
3、Link with product development function, communicate new products or new ingredients’ change proposal, getting the point for pilot trials. 与产品开发功能模块链接, 沟通新产品或新原料设计输入, 理解后期实验目的。
4、Prepare plan of prototype trial, pilot plant trail and trial production. Draft and revise technical regulation, internal quality standard of semi and finished product. Support to set up new product quality standard and analysis method. 完成小试、中试、和试生产研究方案。起草和更改工艺规程、中间产品质量标准和成品内控标准。协助建立新产品质量标准和方法学研究工作。
5、Organize change control and risk analysis before transfer to production, make alignment with all operation functions for the coming trials or validations准备转向生产之前, 进行风险评估和变更控制。组织公司各功能模块就即将进行的实验或验证达成一致方案。
6、According to pilot plant trial plan, conduct pilot plant trial, conduct shelf life and stability test, maintain and keep trial record, to provide sufficient data and necessary technical support to new product development and existed product innovation.根据制定的中试研究方案,实施中试试验,实施产品的有效期和稳定性考察,并维护和保存试验记录,为新产品的开发、现有产品的技术改进提供相关数据及必要的技术支持。
7、According to trial production plan, conduct trial production and stability test cooperating with PPD and QA. Maintain and keep trial record. 根据制定的试生产研究方案,协同生产部门及质量部门,实施试生产和稳定性考察,并维护和保存试验记录。
8、Responsible for sample preparation and management for registration, clinical trial and marketing survey. 负责制备和管理注册样品、临床试验样品和市场调查样品。
9、Stability test and other technical trial required by registration. 完成注册所需的稳定性试验及其他注册相关的技术试验。
10、 Cooperate with technology and process development manager to finish the design, change or confirmation of recipe and technical formula. Cooperate with supervisor to finish related technical training in company. In order to solve technical problems in commercial production, to collect related data and give technology support. 配合工艺技术开发经理完成配方和工艺的设计、更改和确认,配合完成公司内部的相关技术培训。为解决商业生产中的技术难题,与相关部门有效配合,收集相关数据提供技术支持。
11、Responsible to build, maintain and improve the R&D lab management system like GLP. Continuously improve the
daily maintenance of apparatus or equipment in lab and pilot line. Cooperate with technology and process development manager to implement systematical transfer process. 负责研发实验室的体系(GLP)建立、维护与改进。推动中试研究室的仪器和设备的日常维护和保养体系的改进,协助工艺技术开发经理实施系统的产品转移。
12、Responsible for the management of stability test samples, materials and packages, maintain and keep record, give instruction to pilot line assistant for his daily work. 管理中试研究室留样样品、原料和包装材料的管理,并维护和保存记录, 对实验室助理进行工作指导。
13、Fully considering the influence for quality of related work, ensure quality furthest. 对相关工作的充分考虑对产品质量的影响, 最大程度地保证产品质量。
14、While absence, Technology and process development manager will coordinate related work。 While s Technology
and process development manager is absent, this role,the product transfer engineer t will responsible for related work. 本人不在时由工艺技术开发经理协调相应工作. 工艺技术开发经理不在时, 该职位需要负责其相应的工作。
15、Other duties disposed by N+1 supervisor or manager. 上级主管或经理安排的其它工作
岗位要求:
1、Bachelor degree with majored in food or pharmacy.本科学历,食品技术或药学专业
2、2+ years related work experience companies.2年以上相关工作经验
3、Excellent English communication skill (written and verbal)较强的英语听、说、读、写能力
4、Excellent MS office skills能够熟练使用办公软件
5、Super if have the experience for GLP system.具有GLP 管理相关工作经验者佳
6、Good ability in Communication, management, coordination. 良好的沟通、管理、协调能力
公司介绍
纽迪希亚是中国肠内营养理念推广与传播的先行者,目前已经完成了 研发、生产、营销、服务等完整产业生态链的建设。公司主要生产经营肠内临床营养产品(ECN),肠内营养输注产品(Flocare)以及特殊医学用途配方食品(FSMP)。
纽迪希亚坚持以患者为中心,携手政府、医疗机构等社会各方力量,致力于通过创新的产品和业务模式,推动中国医学营养产业的发展,帮助患者延长生命,享受更健康,更有尊严的生活。
联系方式
- Email:HRA@nutricia.com