长沙招聘

工作职责:

Provides strategic and operational leadership for the development and implementation of a consistent quality system in Good Laboratory Practice (GLP) Laboratories in Shanghai, China. Ensures compliance with local and international GLP regulations. Supports the development of a high performing team of QA associates.

在中国上海GLP实验室中，为制定和实施一致的质量体系提供战略和业务领导，确保符合当地和国际GLP法规。支持QA团队的高效发展。

Responsibilities: 职责

? Work with the lead QA management to define the strategy for quality management in GLP Laboratories including continuous process improvement and quality training.

? 与质量保证部主负责人合作，制定GLP实验室的质量管理策略，包括持续的过程改进和质量培训。

? Participate in the expansion of GLP principles and international quality standards (e.g. GCP) to other laboratory areas in WuXi AppTec Co., Ltd. as requested.

? 根据要求，参与GLP原则和国际标准 (如GCP) 在药明康德其他实验室领域的推广。

? Participate in communication with all levels of laboratory personnel and line management on purpose, direction, and goals of quality management.

? 参与与各级实验室人员和汇报线管理人员就质量管理的目的、方向和目标进行沟通。

? Review and approve QA regulatory documents when required.

? 必要时审核和批准QA法规文件。

? Conduct and report QA activities in support of BU regulatory activities, i.e., study inspections/audits, vendor audits, and facility inspections.

? 实施和报告QA活动以支持业务部门的监管活动，即，研究审查/审核，供应商审查和设施审查。

? Assure regulatory authority inspections are fully supported.

? 确保监管机构的检查得到充分支持。

? Provide input to GLP QA SOPs, and BU Operational SOPs.

? 为GLP QA SOP和业务部门运营SOP提供意见。

? Ensure consistent inspection practices of GLP QA operations within China.

? 确保GLP QA在中国区的运营遵守一致的审计程序。

? Assume the responsibilities and role of this position’s supervisor when delegated.

? 在被授权时，承担该岗位上级领导的职责和角色。

? Monitor local projects so that work is on course to meet regulatory or client submission dates.

? 监控本地项目，确保工作正常进行，以满足监管或客户提交日期的要求。

? Oversee local QA work prioritization and resource management.

? 监督本地QA工作的优先级和资源管理。

? Provide local QA groups with general direction and guidance.

? 为本地QA团队提供总体方向和指导。

任职资格:

Qualifications: 资质

? Degree in Science or related experience.

? 理工科或相关经验。

? At least 5 years experience in the quality assurance monitoring of Bioanalytical (LC-MS/MS and ELISA) in research & development and production environments.

? 至少5年研发和生产环境中生物分析(LC-MS/MS和ELISA)质量保证监控经验。

? Understanding of Quality systems and global regulatory (GLP) requirements.

? 理解质量体系和全球监管(GLP)要求。

? Strong communication and negotiation skills.

? 较强的沟通和谈判技巧。

? Excellent interpersonal and leadership skills.

? 优秀的人际关系和领导能力。

? Excellent communication, both written and oral, in English and Mandarin.

? 优秀的中英文书面和口头沟通能力。

Preferred:技能

? Good English skills.

? 良好的英语能力。

? Proactive compliance philosophy.

? 主动合规理念。

? Organization skills.

? 具备组织能力。

? Significant prior experience in GLP QA.

? 丰富的GLP QA经验。

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