Associate Validation Manager ID159555 薪资面议
南昌 5-10年 本科
年底双薪 绩效奖金 带薪年假 交通补助 午餐补助 管理规范 岗位晋升 五险一金 发展空间大 公司规模大
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职位介绍
About Animal Health in China As the multinational animal health company in China, we have extensive business coverage from the full value chain in R&D, production to sales and a diversified product portfolio covering swine, poultry, pets, cattle vaccines and medicines. We are always "in China and for China". We've pioneered many game-changers in the veterinary medicine, and we're looking to our customers' needs to guide us into the future. Job Responsibilities: • Is accountable for maintain and continuously improve the quality and reliability of validation/qualification(Process, Cleaning, Equipment, computer system,spreadsheet) to ensure the Nanchang site are in line with Regulation and business compliance. 负责维护和持续改进南昌工厂验证/确认执行(工艺,清洁,设备,计算机系统,电子表格)的质量和可靠性,以确保符合法规和业务的需求。 • Is accountable for ensure the current validation/qualification procedures (qualification strategy, test aspects required etc.) are strictly followed and continuous improved. 负责确保严格遵守现行验证/确认流程(如验证策略,要求的测试内容等),并持续改进。 • Share technical experience to other qualification/validation units in global, and support technical improvement of global procedure. 与全球其他工厂的确认/验证部门分享技术经验,并支持全球体系的技术改进。 • Act as leader of validation engineers. Develop QV organization, recruit, retain and engage talent to ensure successful implementation of qualification/validation activities in Nanchang. 带领并指导验证工程师的工作,负责发展验证部门,招募、维护和聘用适当人才,以确保南昌工厂确认/验证工作的成功实施。 • Ensure Validation team to maintain the stable support to production. 确保验证团队持续稳定地支持生产。 Job Requirements: • Understanding of live vaccine manufacturing technologies. 熟悉活疫苗生产相关技术。 • Understanding of the regulatory requirements of the live vaccine Industry including a good working knowledge of GMP standards, validation, aseptic processes etc. 熟悉活疫苗行业的法规要求,包括GMP标准,验证和无菌工艺等。 • Minimum 10 years validation working in the pharmaceutical industry. 至少十年制药领域的验证相关工作经验。 • Experience in authority inspections and company audits. 具有监管部门和公司审计的经验。 • Experience in clean utility/cleanroom/HVAC and process equipment. 具有洁净公用系统/洁净室/HVAC和工艺设备验证经验。 • Good problem solving skill, communication skill 良好的解决问题能力和沟通能力

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