锦鲤求职岗位描述
岗位职责：1、管理小组内的日常活动，包括但不限于IPC、最终产品和稳定性样品的抽样测试，新方法的转移/接收和验证，以及分析方法的准备和更新。Management the daily operation in QC small molecule lab, including but not limited to the sampling testing for IPCs, final products and stability samples, the transferring/receiving and validation of new methods, and the preparation and update of analytical methods.2、领导小组内质量控制体系文件的新建及优化，在各个方面都符合内部要求。Lead QC small molecule lab to comply with internal requirements in all aspects via end-to-end quality control system oversight.3、负责QC小分子实验室调查和定义纠正和预防措施期间所需的任何技术/实验工作提供支持和技术指导。Provide support and technical directions for any technical/experiment work required during investigation and definition of corrective and preventive actions in QC small molecule lab.4、监督QC小分子实验室工作人员的培训、评估和管理。指导、发展和支持他们充分发挥潜力。Oversight of the training, evaluation and management of the staff in QC small molecule lab. Coaching, developing and supporting them in reaching their full potential.5、配合QC小分子团队项目、交付计划和持续改进。Matching the projects, delivery plan and continuous improvement in QC small molecule team.6、负责监管部门和客户的GMP审核。回复审计报告并创建 CAPA。Responsible for the GMP audit from regulatory authorities and clients. Reply to audit reports and create CAPAs.7、完成领导安排的其他工作。Completing other interim work assigned by leadership.任职要求：1、本科及以上学历，化学、生物化学、生物学、药学。生物工程或相关领域。Bachelor degree or above, Chemistry, Biochemistry, Biology, Pharmaceutical, Biological Engineering or related field.2、至少8年以上制药行业相关工作经验，其中包括3年的团队管理经验。With NLT 8 years in pharmaceutical industry including NLT 3 years team management experience3、了解小分子药物分析技术，熟悉小分子生产和质量体系。Knowledge of small molecule pharmaceutical analysis technology, familiar with small molecule production and quality system.4、对药物开发过程的整体观点有很好的理解。A good understanding of the overall view of drug development process.5、对cGMP合规的原则和管理有深入的了解，有强烈的质量意识。A thorough understanding of the principles and management of cGMP compliance, and strong quality minds.6、实验室供应管理技能、EHS知识、5S和精益意识。Lab supply management skills, EHS knowledge, 5S and lean sense.7、拥有较好的英语听、说、读、写能力。Perfect for good English listening, speaking, reading and writing skills.