Responsibilities

• Responsible for all site validation programs
• Coordinate with involved departments in validation activities
• Responsible for facility and utility qualification programs
• Responsible for equipment qualification programs
• Responsible for QA role in process and assay validation programs
• Generate validation protocols and reports as required
• Participate in software validation as required
• Maintain and update validation master plans
• Supervisor, lead and train validation staff in execution of validation tasks
• Responsible for contractor’s role and responsibility for validation activities

Qualification

• BS/MS/PhD in life science or related field
• 10+ years experience in drug/biologics industry in GMP production environment
• 5+ years hands on experience in facility, utility, equipment, instrument validation
• Familiar with GMP operational principles and practices
• Works independently, self-motivated, and results oriented
• Good command of English in reading and comprehension at operational level

上班地址：启东滨海高新区

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的最高标准。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。