Analytical Compliance Specialist
中美上海施贵宝制药有限公司 Sino-American Shanghai Squibb Pharmaceuticals Ltd.
- 公司规模:500-1000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:2016-12-09
- 工作地点:上海-闵行区
- 招聘人数:若干人
- 职位类别:生物工程/生物制药
职位描述
职位描述:
"Expected Areas of Responsibilities
工作职责
1. Ensure the SASS Testing Standards complies with the related National Standards.
确保公司内控测试标准符合相关国家药品标准要求。
2. Refering to pharmacopoeia such as USP, EP, ChP. Establish and revise the testing standards and analytial methods.
查阅USP,EP,ChP等相关药典,建立和修改测试标准,检验方法。
3. Ensure the successful method transfer from the BMS to SASS. Support the registration work of new products.
确保总部新产品分析方法及时转移至本地实验室,为新产品注册工作提供支持。
4. Responsible for the development and Validation of new methods.
负责新方法的开发和验证工作
5. Responsible for the verification of compendial methods.
负责法定方法的确认工作。
6. Reponsible for the 3Q of the new instruments. Reponsiple for the management of the Calibration of QC Instrument.
负责新仪器的3Q验证工作,负责QC实验室仪器校验/确认的管理。
7. Responsible for the management of QC Documentation.
负责QC实验室的文件管理。
8. Organize and lead team-members to finish the project on time.
组织和领导团队成员按时完成项目。
9. Investigate the result out of specification, incidents and data deviations in lab and make suggestion to resolve.
调查实验室检验结果超标的情况、实验室数据的异常、偏移情况,并提出处理的建议
10. Establish and revise related SOP.
制订和修改有关标准操作规程。
11. Complete other assignments given by the superior.
按时完成领导交办的其它任务。"
"Experiences Desired
相关工作经验要求
1. At least 2 years experience of quality control or relevant pharmaceutical factory working experience.
2年以上质量控制经验,或相关药厂工作经验
2. Experience of the drug analysis both chemistry and instrument, (UV, HPLC, GC, AA and etc.) or microbiology analysis.
药物的化学和仪器分析经验,包括UV,HPLC,GC和AA等或者微生物分析经验
3. Be familiar with procedure of pharmacopoeia and instrument methods.
熟悉药典和仪器方法
4. Experience of Team-leadership.
团队领导经验"
"Educational/Knowledge Desired (including professional qualifications & language proficiency)
必要的学历和专业资格,含语言能力
1. College Degree or above, Pharmacy, analytical chemistry, Microbiology, Biochemistry and equivalent.
大专以上学历,药学、化学分析、微生物学、生物化学及相关学科相关专业
2. Have an excellent ability to listen, speak, read and write in both English and Chinese.
具有良好的中英文听说读写能力
3. Knowledge of the chemistry or microorganisms.
具备化学或微生物知识
4. Knowledge of GMP.
具备GMP知识
"Skills & Ability Desired
必要的技能和能力
1. Ability to perform basic mathematics.
具备数学基础
2. Skill of basic chemistry analysis or microbiological analysis.
具备基本的化学分析技能或微生物分析技能
3. Skill of referring to pharmacopoeia such as USP, BP, EP, Chp, etc. Participate in establishing or revising testing standard and analyzing methods.
具有查阅 USP、BP、EP、Chp等药典的能力,参与质量标准、检验方法的制订与修改
4. Ability of operate computers, including Excel and Word.
具有计算机操作能力,能运用Excel Word 等软件
5. Ability of effective communication.
具备有效沟通的能力
"
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"Expected Areas of Responsibilities
工作职责
1. Ensure the SASS Testing Standards complies with the related National Standards.
确保公司内控测试标准符合相关国家药品标准要求。
2. Refering to pharmacopoeia such as USP, EP, ChP. Establish and revise the testing standards and analytial methods.
查阅USP,EP,ChP等相关药典,建立和修改测试标准,检验方法。
3. Ensure the successful method transfer from the BMS to SASS. Support the registration work of new products.
确保总部新产品分析方法及时转移至本地实验室,为新产品注册工作提供支持。
4. Responsible for the development and Validation of new methods.
负责新方法的开发和验证工作
5. Responsible for the verification of compendial methods.
负责法定方法的确认工作。
6. Reponsible for the 3Q of the new instruments. Reponsiple for the management of the Calibration of QC Instrument.
负责新仪器的3Q验证工作,负责QC实验室仪器校验/确认的管理。
7. Responsible for the management of QC Documentation.
负责QC实验室的文件管理。
8. Organize and lead team-members to finish the project on time.
组织和领导团队成员按时完成项目。
9. Investigate the result out of specification, incidents and data deviations in lab and make suggestion to resolve.
调查实验室检验结果超标的情况、实验室数据的异常、偏移情况,并提出处理的建议
10. Establish and revise related SOP.
制订和修改有关标准操作规程。
11. Complete other assignments given by the superior.
按时完成领导交办的其它任务。"
"Experiences Desired
相关工作经验要求
1. At least 2 years experience of quality control or relevant pharmaceutical factory working experience.
2年以上质量控制经验,或相关药厂工作经验
2. Experience of the drug analysis both chemistry and instrument, (UV, HPLC, GC, AA and etc.) or microbiology analysis.
药物的化学和仪器分析经验,包括UV,HPLC,GC和AA等或者微生物分析经验
3. Be familiar with procedure of pharmacopoeia and instrument methods.
熟悉药典和仪器方法
4. Experience of Team-leadership.
团队领导经验"
"Educational/Knowledge Desired (including professional qualifications & language proficiency)
必要的学历和专业资格,含语言能力
1. College Degree or above, Pharmacy, analytical chemistry, Microbiology, Biochemistry and equivalent.
大专以上学历,药学、化学分析、微生物学、生物化学及相关学科相关专业
2. Have an excellent ability to listen, speak, read and write in both English and Chinese.
具有良好的中英文听说读写能力
3. Knowledge of the chemistry or microorganisms.
具备化学或微生物知识
4. Knowledge of GMP.
具备GMP知识
"Skills & Ability Desired
必要的技能和能力
1. Ability to perform basic mathematics.
具备数学基础
2. Skill of basic chemistry analysis or microbiological analysis.
具备基本的化学分析技能或微生物分析技能
3. Skill of referring to pharmacopoeia such as USP, BP, EP, Chp, etc. Participate in establishing or revising testing standard and analyzing methods.
具有查阅 USP、BP、EP、Chp等药典的能力,参与质量标准、检验方法的制订与修改
4. Ability of operate computers, including Excel and Word.
具有计算机操作能力,能运用Excel Word 等软件
5. Ability of effective communication.
具备有效沟通的能力
"
职能类别: 生物工程/生物制药
公司介绍
百时美施贵宝是一家以“研发并提供创新药物,帮助患者战胜严重疾病”为使命的全球性生物制药公司。
2019年11月20日,百时美施贵宝成功完成了对新基的收购,将双方在领先的科学、创新的药物和优秀的人才等方面的优势合二为一,打造全球领先的生物制药企业。公司在肿瘤、血液、免疫和心血管疾病等领域处于世界前列,并具有丰富的,且具有行业前景的产品管线。
如今,中国已是百时美施贵宝公司全球重要的研发、生产、营销和创新中心之一。我们致力于满足中国未被满足的迫切的重大疾病需求,引领行业发展,开展多元合作,以帮助中国患者战胜严重疾病。
2019年11月20日,百时美施贵宝成功完成了对新基的收购,将双方在领先的科学、创新的药物和优秀的人才等方面的优势合二为一,打造全球领先的生物制药企业。公司在肿瘤、血液、免疫和心血管疾病等领域处于世界前列,并具有丰富的,且具有行业前景的产品管线。
如今,中国已是百时美施贵宝公司全球重要的研发、生产、营销和创新中心之一。我们致力于满足中国未被满足的迫切的重大疾病需求,引领行业发展,开展多元合作,以帮助中国患者战胜严重疾病。
联系方式
- 公司地址:地址:span南京