Full Time

DP Filling Engineer

Posted 1 month ago
Application ends: November 17, 2021
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Job Description

BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

Job Description

Academic/ Professional Qualification

学历/专业资格

  • Junior college or above in Pharmacy, Chemistry, Microbiology or related major.

药学、化学、微生物学或相关学科大专或以上学历。

Technical/Skills Require

技术/技能训练

  • With aseptic filling skills and good aseptic consciousness.

无菌分装技能,良好无菌意识。

  • Familiar with regulations and principle of GMP.

熟悉GMP法规及指导原则。

Working Experience

工作经验

  • Above 3 years’ experience in pharmacy company.

3年以上制药行业工作经验。

  • Above 1 years’ filling experience.

至少1年无菌注射剂生产工作经验。

Language, Computer Literacy, Office Software, etc.

语言能力,电脑知识,办公软件等

  • Good English in written. Good office software skills.

英语良好,熟悉电脑办公软件。

Others其他

Ÿ Positive, dedicated, Progressive, Responsibility and Integrity.

积极敬业、主动进取、责任心强、正直向上。

Ÿ Some ability in decision-making.

具有一定的判断和决策能力。

Ÿ Good communication.

具有良好的合作精神。

Ÿ Obey the arrangement.

服从领导安排。

Qualification Required

  • Assist the management of document system and quality

协助车间文件体系和质量管理

 Assist filling leader to establish the document system.

协助灌装负责人领导下,协助灌装车间的文件体系的建立。

 Assist draft the process description, batch record and SOP/WI.

协助车间工艺规程、批生产记录、操作程序等技术性文件的编写及审核。

 Assist execute the qualification of utility and equipment and PV.

协助完成厂房设施确认、设备确认、工艺验证。

  • Filling manufacturing

灌装生产

 Execute the production according to plan.

根据车间下达的生产计划,保质保量、按时按量完成灌装任务。

 Assist the staff training and ensure operation compliance with SOP/WI. And record the GMP form on time with good GDP.

协助灌装人员的文件和安全培训,督促人员按照SOP进行操作,并正确填写各类GMP文件记录,对违反GMP和SOP 的操作行为进行指正。

 Assist the cost control and establish the list of materials.

负责灌装物料的使用管理,避免物料的不合理使用及浪费,以降低生产成本。

 Assist improve the filling efficiency.

协助负责人或技术人员对灌装工序进行工艺技术改进,提高产品质量和收率。

 Support to deviation investigation, change control and CAPA follow up.

协助偏差调查、变更控制和CAPA处理。

  • EHS

 Comply with EHS regulations to ensure safe and civilized production.

遵守EHS的各项规定,确保安全文明生产。

  • Others其它

 Any other assignment as is determined by supervisor.

完成上级安排的其它工作。

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