QC工程师 (微生物)
上海合全药业有限公司
- 公司规模：1000-5000人
- 公司性质：合资(欧美)
- 公司行业：制药/生物工程
职位信息
- 发布日期：2017-05-24
- 工作地点：上海-浦东新区
- 招聘人数：2人
- 工作经验：3-4年经验
- 学历要求：本科
- 职位月薪：0.8-1.5万/月
- 职位类别：质量管理/测试工程师(QA/QC工程师) 生物工程/生物制药
职位描述
职位描述：
Responsibilities:
1. Perform microbial test: method development, method validation and test of drug substances,product, raw materials.
2. Monitor GMP clean area periodically according to the requirement of SOP.
3. Perform sample analysis including but not limited to GMP drug substances and products used forclinical trials.
4. Manage the working organisms and the microbial lab cleaning.
5. Assume responsibility for assigned instruments, maintaining them in proper calibration andworking status according to the appropriate SOP; Perform IQ/OQ/PQ/PC as assigned.
6. Write up IQ/OQ/PQ/PC protocols and/or protocol, method or report related to microbial testing.
7. All work will be conducted in compliance with cGMP/GLP regulations when applicable.
8. Be expected to perform the job independently with limited supervision from senior scientists,group leaders and senior management.
9. Must be customer-oriented and able to show flexibility and ability to work with multiple projects.Must be able to prioritize the workload to meet the pre-determined timelines.
10. Individuals will be expected to accomplish their work assignments by interacting closely withfellow scientists and by developing cooperative working relationships with other personnel insidethe company.
11. Good communication, open exchange of information and project teamwork will be required inorder to meet job performance. There must be strong recognition of high performance standardsand of meeting assignment target dates at the individual job level as well as for the benefit of coworkers on project teams.
Qualifications:
1. Must have experience in microbial test and familiar with biological safety practice.
2. Must be trained in or be familiar with the requirements of the FDA cGMP/GLP regulations, ICHguidelines as well as drug development process.
3. BS, MS or Ph.D. degree in microbiology or other directly-related science discipline withexperience or training in pharmaceutical analysis.
4. Must be experienced with standard analytical techniques, particularly incubator, colony counter,autoclave, Biotest RCS Air sampler etc.
5. Strong communication skills, both written and verbal, and outstanding interpersonal skills areessential job requirements.
6. Must be able to work in a team-oriented manner in order to accomplish performance objectives.
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Responsibilities:
1. Perform microbial test: method development, method validation and test of drug substances,product, raw materials.
2. Monitor GMP clean area periodically according to the requirement of SOP.
3. Perform sample analysis including but not limited to GMP drug substances and products used forclinical trials.
4. Manage the working organisms and the microbial lab cleaning.
5. Assume responsibility for assigned instruments, maintaining them in proper calibration andworking status according to the appropriate SOP; Perform IQ/OQ/PQ/PC as assigned.
6. Write up IQ/OQ/PQ/PC protocols and/or protocol, method or report related to microbial testing.
7. All work will be conducted in compliance with cGMP/GLP regulations when applicable.
8. Be expected to perform the job independently with limited supervision from senior scientists,group leaders and senior management.
9. Must be customer-oriented and able to show flexibility and ability to work with multiple projects.Must be able to prioritize the workload to meet the pre-determined timelines.
10. Individuals will be expected to accomplish their work assignments by interacting closely withfellow scientists and by developing cooperative working relationships with other personnel insidethe company.
11. Good communication, open exchange of information and project teamwork will be required inorder to meet job performance. There must be strong recognition of high performance standardsand of meeting assignment target dates at the individual job level as well as for the benefit of coworkers on project teams.
Qualifications:
1. Must have experience in microbial test and familiar with biological safety practice.
2. Must be trained in or be familiar with the requirements of the FDA cGMP/GLP regulations, ICHguidelines as well as drug development process.
3. BS, MS or Ph.D. degree in microbiology or other directly-related science discipline withexperience or training in pharmaceutical analysis.
4. Must be experienced with standard analytical techniques, particularly incubator, colony counter,autoclave, Biotest RCS Air sampler etc.
5. Strong communication skills, both written and verbal, and outstanding interpersonal skills areessential job requirements.
6. Must be able to work in a team-oriented manner in order to accomplish performance objectives.
职能类别： 质量管理/测试工程师(QA/QC工程师) 生物工程/生物制药
关键字： QC 质量 品质 医药 微生物
公司介绍
合全药业是在中美两地均有运营的药明康德子公司，服务于生命科学行业，拥有卓越的化学创新药研发和生产的能力和技术平台。作为全球新药合作研究开发生产领域（CDMO）的领军企业，合全药业致力于为全球合作伙伴提供从原料药（API）到制剂，高效、灵活、高质量的一站式解决方案。
合全金山工厂占地14英亩，是cGMP的生产基地，金山工厂能够生产从公斤级到吨级的产品，包含一个公斤级实验室、两个中试车间和一个商业化车间，反应釜体积从5 L至20,000 L，还包含一个cGMP的高活性原料药生产设施、质量控制实验室、仓库和溶剂罐区。
合全金山工厂分别于2013、2014、2016年和2018年四次通过美国FDA检查，得到8个国际监管机构批准，可为美国、欧洲、日本、加拿大、瑞士、澳大利亚、新西兰和中国的生产商业化创新原料药（APIs）
金山工厂配备有先进的生产设备，具有经验丰富的技术人员，可生产多种反应类型的产品，如不对称催化氢化、对空气和水敏感的金属催化、高温、高压、低温和氧化反应。此外，还可使用高技术生产工艺，如高体积液氮、连续化工艺（流体化学）和生物催化。
目前公司正在飞速发展，需要向社会招聘更多的优秀人才以壮大我们的队伍，与公司共创美好的未来。诚意邀请您的加盟！
公司网址：****************************
合全金山工厂占地14英亩，是cGMP的生产基地，金山工厂能够生产从公斤级到吨级的产品，包含一个公斤级实验室、两个中试车间和一个商业化车间，反应釜体积从5 L至20,000 L，还包含一个cGMP的高活性原料药生产设施、质量控制实验室、仓库和溶剂罐区。
合全金山工厂分别于2013、2014、2016年和2018年四次通过美国FDA检查，得到8个国际监管机构批准，可为美国、欧洲、日本、加拿大、瑞士、澳大利亚、新西兰和中国的生产商业化创新原料药（APIs）
金山工厂配备有先进的生产设备，具有经验丰富的技术人员，可生产多种反应类型的产品，如不对称催化氢化、对空气和水敏感的金属催化、高温、高压、低温和氧化反应。此外，还可使用高技术生产工艺，如高体积液氮、连续化工艺（流体化学）和生物催化。
目前公司正在飞速发展，需要向社会招聘更多的优秀人才以壮大我们的队伍，与公司共创美好的未来。诚意邀请您的加盟！
公司网址：****************************
联系方式
- 公司网站：****************************
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- Email：sh@wuxiapptec.com
- 公司地址：月工路9号