上海招聘

Quality Assurance Manager （Quality Systems)

Responsibilities

• Responsible for quality systems setup, maintenance and improvement
• Lead department effort in change control, deviation, CAPA,
• Define, implement raw material qualification and receiving/inspection programs
• Define, implement in-process QA oversight
• Define, implement product release process
• Lead and direct deviation management as QA representative
• Lead and direct OOS investigation and closure from QA perspective
• Manage change control to meet requirements of internal and customer requirements
• Manage CAPA system to ensure continued monitoring and progress
• Participate in other quality systems maintenance, improvement and management as required

                      

Qualification

• BS/MS/PhD in life science or related field
• 7+ years experience in drug/biologics quality assurance
• Clear understanding of pharma quality assurance principles and practices
• Excellent personal skills, with ability to lead and influence by example
• Works independently, self-motivated, and results oriented
• Ability to read and write in English at technical and operational levels

              

  

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。