上海招聘

Responsibilities 职责

• Maintain and update annual validation plans

• 维护和更新验证年度计划

• Maintain and update project validation plans as required

• 根据需要维护和更新项目验证计划

• Prepare and/or review qualification and validation related assessment report, protocols, and reports

• 起草与/或审核确认与验证相关的评估报告、方案及报告

• Participate in the handling of qualification and validation related deviations

• 参与确认与验证相关的偏差处理

• Supervise the service provided by a contractor.

• 监督由验证承包商提供的验证服务

• Operate validation instruments, eg. validator, photometer, particle counter, etc.

• 负责验证用仪器的操作，例如，验证仪、光度计、粒子计数器等

• Review or participate in FAT/SAT as required

• 必要时，审核或参与FAT/SAT

• The qualification and validation activities to be involved includes but not limit to: facility and utility qualification, temperature controlled unit qualification, process equipment qualification, analytical instrument qualification, computerised system validation, analytical method validation, cleaning validation, process validation

• 需要涉入的确认与验证活动包括但不限于：设施及公用工程确认，温控单元确认，工艺设备确认，分析仪器确认，计算机化系统确认，分析方法验证，清洁验证，工艺验证
  
  Qualification资格要求

• Bachelor degree or above in biology, pharmacy or related field

• 生物、制药或相关专业本科及以上学历

• 1+ years hands on experience in the qualification or validation. 3+ years’ experience in pharmaceutical industry (biopharmaceutical industry preferred) with good understanding of validation

• 1年以上确认或验证工作经验；或者3年以上医药行业经验（生物制药行业更佳），但是对验证工作有很好的理解。

• Familiar with GMP operational principles and practices

• 熟悉GMP操作原则和规范

• Familiar with validation related regulatory standards and industry guidance

• 熟悉验证相关法规要求及行业指南

• Good command of English in reading comprehension

• 具有良好的英语阅读理解能力

• Good communication and collaboration skills

• 良好的沟通及协作能力

• Skilled in MS software

• 熟练操作办公软件

凯惠睿智生物科技（上海）有限公司于2015年成立，位于上海张江睿智化学主园区，专注于生物大分子制剂CMC开发，具备完善的生物大分子临床前开发能力。公司规模涵盖实验室研发，中试生产，临床前制剂灌装以及临床样品制备，成功推进多项抗体新药的临床试验申报和新药上市。凯惠睿智提供一站式服务，包括稳定细胞株开发、细胞库建立、细胞发酵生产，下游纯化、制剂生产、无菌灌装和冻干工艺开发，同时具备完整的QA质量监督体系，遵守并执行ICH指导原则以及CFDA,FDA和EMA的***标准。公司在抗体药物临床前开发方面，具有雄厚的研发实力和生产能力。