
M&S-Senior QC Specialist-Beijing
- 北京市
- 长期
- 全职
- Location工作地点: Beijing 北京
- % Remote working and % of travel expected 远程办公和出差的概率:3%
- Job type工作类型: Full time全职
- Site/Unit 区域/事业部:Manufacturing & Supply制造与供应事业部
- To carry out QC analyses in compliance with analytical methods/protocols/specifications, follow good documentation practices, CGMP, safety health and environmental.按照分析方法/方案/标准进行理化实验,遵守良好文件记录和GMP以及环境/安全/健康的要求。
- Specifically, 具体为According to the test methods/protocols/specifications to carry out analytical testing for samples of semi-finished products, finished products, API, excipients, packaging material, Medical devices, cleaning validation/verification and pharmaceutical water, etc.. /方案/标准对半成品,成品,原辅料,包材,医疗器械,清洁验证/确认和制药用水等样品; Perform the sampling of raw materials, active ingredients, packaging materials, imported bulks, cleaning validation/verification and pharmaceutical water.
- According to the protocol to carry out the method validation and instrument qualification, and can identify and raise up the defect in time.
- Ensure that analyses are carried out in time. Execute lab investigations and the quality assessment.
- Maintain the availability of test equipment together with supplier and maintenance technician.
- Carry out the maintenance of laboratory equipment according to the established schedules and maintain accurate records and archive.
- (Assist and) draft of work-related SOPs, testing record template, qualification protocols/reports of the analytical instruments and the analytical methods. Perform the qualification work. /报告及分析方法,并进行相关验证工作; Pay attention on the number of available reagents, column, reference standards and other testing relates consumables ensure proper amount can be used. Manager archives of columns.
- Take assigned 5S responsibilities. 5S分配任务。 Engaged in the lab continuously improvement of technical and management purpose. Advocate and execute the SMS concept and practice.
- Execute other works which is assigned by superior.
- Proactively response to HSE management works to prevent each type of accident, and proactively propose HSE related feedbacks or advices.
- Actively propose energy-saving projects
- Support the development of energy-saving projects and give positive feedback
- Participate in and implement energy-saving projects
- Participate in internal audit of energy management system
- Experience: Have Pharmacy GMP lab working more than 3 years of experience.
- Soft skill: Communication, problem solving oriented. Good problem-solving skills and initiative.
- Technical skill: a good knowledge of Chinese and international GMP, DI are required. Experience in ICP-MS use and maintenance is preferred.
- Education: related disciplines such as chemistry, biochemistry, pharmacy, microbiology etc. Bachelor degree or above.
- Languages: Good at English writing, reading, listening and spoken
- Take The Lead Behaviours:Aim Higher、Act for Patients、Be Bold and Lead Together