GMP Compliance Leader (Auditor/QA)
上海药明康德新药开发有限公司
- 公司规模:10000人以上
- 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:2017-03-23
- 工作地点:上海-浦东新区
- 招聘人数:1人
- 学历要求:专业培训
- 职位月薪:0.9-1.5万/月
- 职位类别:药品生产/质量管理 生物工程/生物制药
职位描述
职位描述:
Key accountabilities:
1. Responsible for assurance of high compliance of GMP staff in daily operation
2. Responsible for coordination and successful completion of audit from QA, clients and regulatory agencies
3. Responsible for tracking of compliance performance of all GMP manufacturing staff
4. Responsible for continuous improvement of manufacturing practice to ensure strict compliance to internal SOP, guideline from regulatory agencies
5. Responsible for GMP documentation writing including but not limited to SOP, deviation, investigation, etc.
6. Conduct daily GMP compliance inspection in GMP suites
7. Responsible for cleaning sampling
Requirements:
? BS degree or other directly-related science discipline with experience or training in pharmaceutics quality or equivalent experience.
? Preferably be trained and have experience in formulation/dose development & process development.
? Have English training experience or good in English speaking, writing, reading and also listening.
? Strong communication and coordinate skills, both written and verbal, and outstanding interpersonal skills are essential job requirements.
? Be able to work in a team-oriented manner in order to accomplish performance objectives.
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Key accountabilities:
1. Responsible for assurance of high compliance of GMP staff in daily operation
2. Responsible for coordination and successful completion of audit from QA, clients and regulatory agencies
3. Responsible for tracking of compliance performance of all GMP manufacturing staff
4. Responsible for continuous improvement of manufacturing practice to ensure strict compliance to internal SOP, guideline from regulatory agencies
5. Responsible for GMP documentation writing including but not limited to SOP, deviation, investigation, etc.
6. Conduct daily GMP compliance inspection in GMP suites
7. Responsible for cleaning sampling
Requirements:
? BS degree or other directly-related science discipline with experience or training in pharmaceutics quality or equivalent experience.
? Preferably be trained and have experience in formulation/dose development & process development.
? Have English training experience or good in English speaking, writing, reading and also listening.
? Strong communication and coordinate skills, both written and verbal, and outstanding interpersonal skills are essential job requirements.
? Be able to work in a team-oriented manner in order to accomplish performance objectives.
职能类别: 药品生产/质量管理 生物工程/生物制药
关键字: GMP 生产 QA 质量 审计 生产管控
公司介绍
药明康德是国际领先的开放式能力与技术平台公司,为全球制药及医疗器械等领域提供从药物发现、开发到市场化的全方位一体化的实验室研发和生产服务。本着以研究为首任,以客户为中心的宗旨,药明康德通过高性价比、高效率的服务平台帮助全球客户缩短药物及医疗器械研发周期、降低研发成本。药明康德平台涵括化学药研发和生产、细胞及基因疗法研发生产、药物研发和医疗器械测试等,正承载着来自全球30多个国家的3500多家创新合作伙伴的数千个研发创新项目,致力于将最新和***的医药和健康产品带给全球病患,实现“让天下没有难做的药,难治的病”的梦想。
联系方式
- Email:zhuyun@wuxiapptec.com
- 公司地址:江北新区华康路122号南京生物医药谷加速器四期07栋
- 电话:15738851478