锦鲤求职岗位描述
Responsibilities:1.负责监管区域的现场的日常质量监管包括虫控监督，确保各项GMP工作按照SOP和对应程序执行;Responsible for routine quality oversight for responsible areas including pest control to ensure all GMP activities are executed based on SOPs and related procedures.2.确保完成各种必要的确认或验证工作，审核和批准确认或验证方案和报告。To ensure the completion of various necessary validation and qualification work, review and approve the validation protocol and report.3.监督厂房和设备的维护，以保持其良好的运行状态；To supervise the maintenance of the plant and equipment to keep it in good operating condition.4.负责审批工程、验证及虫控相关文件，如：Responsible for review and approval of WuXi XDC related engineering, validation and pest control management documents. Such as:4.1批准工程、验证及虫控相关质量管理的操作规程及相关记录、方案和报告等；To approve quality related management procedures and record, protocol and reports, etc from engineering, validation and pest control;4.2负责监督区域的偏差、变更、CAPA的审核批准。Responsible for review and approval for GMP areas-initiated deviation, change control, CAPA.5.参与企业质量体系建立、内部自检、投诉、产品召回等质量管理活动；To participate in quality management activities such as the establishment of corporate quality system, internal self-inspection, complaint, product recalls, etc.6.负责支持各类GMP审计和检查工作。Responsible for supporting GMP audits and inspections.7.监督负责区域以及下属员工所有相关人员都已经过必要的上岗前培训和继续培训；To supervise the oversight areas and subordinates that all relevant personnel of the company have received necessary pre-job training and continuing training.8.确保记录的保存，确保各种数据符合数据可靠性要求;To ensure record keeping, ensure all kinds of data meet data integrity requirements9.支持QA项目管理以及其他团队的相关的工作。Support QA project management and other teams’ relevant works.10.承办领导交予的其他任务。Deal with other tasks assigned by line manager.Qualifications:1.化学、生物化学、生物学、药学本科及本科以上学历。生物工程或相关领域。Bachelor’s degree or above in Chemistry, Biochemistry, Biology, Pharmaceutical. Biological Engineering, or related field.2.具有至少15年从事药品生产和质量管理的实践经验。At least 15 years of practical experience in pharmaceutical manufacturing and quality management.3.熟悉US/中国/欧盟法规及ICH等的要求。Familiar with US/China/EU and ICH GMP requirement.4.熟悉无菌药品生产，熟悉质量体系。Familiar with sterile pharmaceutical production and quality system.5.熟悉US/中国/欧盟法规及ICH等的要求。Familiar with US/China/EU and ICH GMP requirement.6.熟悉无菌药品生产，熟悉质量体系。Familiar with sterile pharmaceutical production and quality system.7.良好的沟通协作能力。Good communication and coordination skills.8.良好的计算机办公技能。Good computer skills.9.良好的英文听说读写能力尤佳。Perfect for good English listening, speaking, reading and writing skills.