齐女士
3天前在线
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- 职位介绍
- 固体制剂
- 制剂
- 临床QA
- Roles & Responsibility 主要职责 · New equipment investigation and qualification, such as URS, IQ, OQ, PQ. · Work with CMC team to transfer the product to clinical or commercial production. · Participate in new plant construction, such as drawing review, construction supervision. · Organize personnel in various positions in the workshop to develop and improve job responsibilities, review work plans of subordinates, and provide training, guidance, and performance evaluation for personnel business development. · Develop and review various rules and regulations, process procedures, SOP, BPR and other documents, review the legality and feasibility of the documents, and supervise the effective implementation of the documents. · Develop monthly production plans for the workshop, submit and review procurement requests for various materials and supplies, complete production tasks with quality and quantity assurance, ensure product quality, and ensure market supply. · Promote the construction of workshop teams and echelons, select outstanding personnel, and cultivate and reserve talents. · Responsible for workshop cost management, improving production efficiency and reducing production costs. · Ensure that all applicable Safety, Health & Environment requirements are fulfilled to comply with corporate group policy and local legal requirements. · 参与新设备调研和确认，如URS、IQ、OQ、PQ。 · 与CMC团队合作，将产品转移到临床或商业生产中。 · 参与新工厂的建设，如图纸审查、施工监督。 · 组织车间各岗位人员制订、完善岗位职责，对下属人员的工作计划进行审核，对人员业务开展进行培训、指导和绩效评估。 · 制定和审核车间各类规章制度、工艺规程、SOP、BPR等文件，对文件的合法性、可行性进行审核，监管文件有效执行。 · 制定车间月度生产计划，并提交和审核各类物料、物资的采购申请，保质保量完成生产任务，保证产品质量，保障市场供货。 · 推进车间团队、梯队建设，选拔优秀人员，培养和储备后备人才。 · 负责车间成本管理工作，提高生产效率、降低生产成本。 · 确保满足所有适用的安全、健康和环境要求，以符合企业集团政策和当地法律要求。 Job Requirement 工作要求 · Bachelor or above major in pharmacy or related field. · More than 5 years of experience in solid formulation production supervisor. · Experience in transferring new drug varieties for solid formulations, with priority given to innovative drug experience. · Experience in new site project is preferred. · Skill in using computer and office software. · Strong communication skills, workable English. · Critical thinking, scientific reasoning and problem solving skills. · Experience on training staffs and team building. · 本科及以上，药学相关专业。 · 固体制剂生产主管经验5年以上。 · 具有固体制剂新药品种转移经验，创新药经验优先。 · 有新址项目经验者优先。 · 熟练使用电脑和办公软件。 · 沟通能力强，英语流利。 · 批判性思维、科学推理和解决问题的技能。 · 培训员工和团队建设方面的经验。
- 其他信息
- 行业要求：全部行业
公司简介
迪哲医药（股票代码：688192）是一家创新型生物医药企业，专注于恶性肿瘤、免疫性疾病领域创新疗法的研究、开发和商业化。公司坚持源头创新的研发理念，以推出全球首创药物（First-in-class）和具有突破性潜力的治疗方法为目标，旨在填补全球未被满足的临床需求。基于行业领先的转化科学和新药分子设计与筛选技术平台，公司已建立了五款具备全球竞争力的产品管线，两大领先产品处于全球关键性临床试验阶段，其中一款已获批上市。
Dizal Pharmaceutical Co., Ltd (Ticker: 688192 ) is a commercial stage biopharmaceutical company. At Dizal we aspire to discover and develop differentiated therapeutics for the treatment of cancer and immunological diseases. Building on our extensive expertise in translational science and molecular design, we have established an internationally competitive portfolio of five clinical-stage assets with two leading assets in global pivotal studies and one already approved.
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