
M&S-QC Technician-Beijing
- Beijing
- Permanent
- Full-time
- 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, 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,制药用水,清洁验证/确认等样品,执行分析检验; Perform the sampling of raw materials, active ingredients, packaging materials, imported bulks, cleaning validation/verification and pharmaceutical water.
- Lab related SAP data maintenance. SAP数据维护;
- 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; Print and manage lab related logbook. logbook。 Assist GAP analyses between global requirement and local authority standard.
- 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.
- Provide technical support to official testing.
- Perform activities related with Medical Device according to the current Good Supply Practice (GSP) regulations. GSP)执行医疗器械相关活动。 Take assigned 5S responsibilities. 5S分配任务。 Perform activities related with Medical Device according to the current Good Supply Practice (GSP) regulations. 依据现行经营管理规范(GSP)执行医疗器械相关活动 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 experience.
- Soft skill: Communication, problem solving oriented. as well as a good knowledge of Chinese and international GMP are required.
- Technical skill: a good knowledge of Chinese and international GMP, DI are required.
- Education: related disciplines such as chemistry, biochemistry, pharmacy, microbiology etc.
- Languages: Good at English writing, reading, listening and spoken
- Take The Lead Behaviours:Aim Higher、Act for Patients、Be Bold and Lead Together