QA Senior Manager (GLP QA)
方达医药技术（上海）有限公司
- 公司规模：150-500人
- 公司性质：外资(欧美)
- 公司行业：制药/生物工程
职位信息
- 发布日期：2015-02-04
- 工作地点：上海-浦东新区
- 招聘人数：1
- 工作经验：5-7年
- 学历要求：硕士
- 语言要求：英语
- 职位月薪：面议
- 职位类别：药品生产/质量管理
职位描述
JOB SUMMARY
The Senior Manager of the Quality Department is responsible to establish and maintain quality system. The candidate should have at least 5 years of experience in a senior quality assurance position within a drug development company or CRO company with good understanding of quality system and practical experience of implementation.
Job Descriptions:
1. Assist QA Management with Implementation, maintenance and enhancement of quality proceduresand systems to ensure compliance with USFDA, OECD, ICH, and SFDA regulatory requirementsand other relevant guidance and publications.
2. Ensure that requirements and documentation for all regulated systems are kept current according to ever-changing guidelines and industry standards.
3. Review and maintain up-to-date Standard Operating Procedures (SOP).
4. Conduct QA audits of bio laboratories and functions including but not limited to: on-going process, data review audits, technical report, and study independent facility / process.
5. Effectively report quality issues to supervisor, Study Director, QA Management, and Frontage management, as appropriate.
6. Provide input to method, equipment, computer validation programs, if required by client or BIO lab.
7. Host or help to host external audit/inspection including client QA audit and regulatory agencies inspection as needed.
8. Maintain appropriately detailed notes, audit reports, and records.
9. Provide Regulatory training to staff as necessary.
10. Oversee work of junior QA staff.
11. Other tasks as assigned
Requirements:
1. MS in chemistry, pharmaceutics or related field with 5+ years of relevant experience in the Pharmaceutical Industry, CRO company experience preferred.
2. Good written and oral communications skills in both Chinese and English.
3. Strong project management skills a requirement. Must be able to begin a new project and quickly map out the key milestones and accompanying necessary tasks on a comprehensive timeline.
4. Multi-tasking necessary. Must be able to work on several projects simultaneously.
5. Must have a positive work attitude and be able to see multiple challenges as opportunities.
The Senior Manager of the Quality Department is responsible to establish and maintain quality system. The candidate should have at least 5 years of experience in a senior quality assurance position within a drug development company or CRO company with good understanding of quality system and practical experience of implementation.
Job Descriptions:
1. Assist QA Management with Implementation, maintenance and enhancement of quality proceduresand systems to ensure compliance with USFDA, OECD, ICH, and SFDA regulatory requirementsand other relevant guidance and publications.
2. Ensure that requirements and documentation for all regulated systems are kept current according to ever-changing guidelines and industry standards.
3. Review and maintain up-to-date Standard Operating Procedures (SOP).
4. Conduct QA audits of bio laboratories and functions including but not limited to: on-going process, data review audits, technical report, and study independent facility / process.
5. Effectively report quality issues to supervisor, Study Director, QA Management, and Frontage management, as appropriate.
6. Provide input to method, equipment, computer validation programs, if required by client or BIO lab.
7. Host or help to host external audit/inspection including client QA audit and regulatory agencies inspection as needed.
8. Maintain appropriately detailed notes, audit reports, and records.
9. Provide Regulatory training to staff as necessary.
10. Oversee work of junior QA staff.
11. Other tasks as assigned
Requirements:
1. MS in chemistry, pharmaceutics or related field with 5+ years of relevant experience in the Pharmaceutical Industry, CRO company experience preferred.
2. Good written and oral communications skills in both Chinese and English.
3. Strong project management skills a requirement. Must be able to begin a new project and quickly map out the key milestones and accompanying necessary tasks on a comprehensive timeline.
4. Multi-tasking necessary. Must be able to work on several projects simultaneously.
5. Must have a positive work attitude and be able to see multiple challenges as opportunities.
公司介绍
方达医药全球型全方位新药研发外包服务公司（CRO）,于2001年成立于美国，总部位于宾夕法尼亚州费城西郊的埃克斯顿。2006年成立方达医药技术（上海）有限公司，在苏州和郑州分别设有分公司和管理团队。2019年5月30日，方达控股（方达医药上市主体）成功登陆香港联交所主板，股票代码*******。
方达医药始终坚持“中美两国，同一质量体系”准则，获得数据可用于全球申报，目前已为全球400多家客户提供高质量、高标准的新药和仿制药研发服务。作为中国制药企业国际化及高端药物研发合作伙伴，方达医药拥有技术熟练的专业团队，配备了国际最先进的药物研发仪器和设备，并努力为客户创造友好轻松的合作和沟通环境。专注于一体化的专业服务，业务范围包括生物分析、BE临床服务、CMC药品制剂研发、cGMP咨询及国际药品注册等服务项目。
● 我们为员工提供全面的福利待遇，并履行对员工健康和福利的全面承诺。
● 我们为员工提供了与***制药公司合作的机会，让其成为药物开发过程的关键贡献者。
● 我们为员工提供良好的职业发展机会，确保员工在行业内不断积累经验。
● 我们的员工是最有价值的资产，我们拥有明确的员工奖赏计划，肯定员工的奉献精神，奖励员工的辛勤付出。
您也可以发送简历至招聘邮箱：recruitment@frontagelab.com.cn
更多信息请浏览公司网站：**********************
方达医药始终坚持“中美两国，同一质量体系”准则，获得数据可用于全球申报，目前已为全球400多家客户提供高质量、高标准的新药和仿制药研发服务。作为中国制药企业国际化及高端药物研发合作伙伴，方达医药拥有技术熟练的专业团队，配备了国际最先进的药物研发仪器和设备，并努力为客户创造友好轻松的合作和沟通环境。专注于一体化的专业服务，业务范围包括生物分析、BE临床服务、CMC药品制剂研发、cGMP咨询及国际药品注册等服务项目。
● 我们为员工提供全面的福利待遇，并履行对员工健康和福利的全面承诺。
● 我们为员工提供了与***制药公司合作的机会，让其成为药物开发过程的关键贡献者。
● 我们为员工提供良好的职业发展机会，确保员工在行业内不断积累经验。
● 我们的员工是最有价值的资产，我们拥有明确的员工奖赏计划，肯定员工的奉献精神，奖励员工的辛勤付出。
您也可以发送简历至招聘邮箱：recruitment@frontagelab.com.cn
更多信息请浏览公司网站：**********************
联系方式
- Email：recruitment@frontagelab.com.cn
- 公司地址：地址：spanhomebase