验证小组负责人

该职位来源于猎聘 验证小组负责人 1

建立和健全公司验证策略，并保证成本控制； Establish and improve company validation strategies and ensure cost control. 2

公司各产品线工厂验证总计划制定与管理； Establish and manage the site validation master plan for all the production lines. 3

汇编公司各无菌产品生产线的污染控制策略，并确保其周期性回顾和更新； Compile the contamination control strategies for all aseptic production lines in the company and ensure their periodic review and updates. 4

建立和持续改进验证相关规程，并确保验证活动按照计划和规程执行； Establish and continuously improve validation related procedures, and ensure that validation activities are carried out according to the plan and procedures. 5

监督验证活动的执行，确保符合法规和公司要求； Supervise the execution of validation activities to ensure compliance with regulations and company requirements. 6

验证方案、报告等验证文件的审核和批准； Review and approval of validation documents, like protocols and reports. 7

确保部门人员经过必要的上岗前培训和继续培训，并根据实际需要调整培训内容； Ensure that department personnel receive necessary pre-job training and ongoing training, and adjust training content as needed. 8

跟踪相应法规进展，并培训下属，持续提升其综合素质； Track relevant regulations and train subordinates to continuously improve their overall quality. 9

培训用户及验证/校准相关部门（工程部门等）或验证服务供应商，按照本公司验证相关规程要求执行验证活动； Train users and verify/calibrate relevant departments (engineering departments, etc.) or verify service providers to carry out verification activities in accordance with the company's verification requirements. 10

确保验证结论和已验证的参数落实在相应的规程中，准确指导日常生产和检验工作； Ensure that the validation conclusions and validated parameters are implemented in the corresponding procedures to accurately guide daily production and inspection work. 11

参与内部外部质量审计； Participate in internal and external quality audits. 12

参与偏差、变更、CAPA调查和质量风险评估； Participate in deviation, change, CAPA investigation, and quality risk assessment. 13

建立和维护符合公司发展要求的验证支持组团队； Establish and maintain a validation support team that meets the company's development requirements. 14

指导、管理下属，保证严格按照文件规定执行，正确履行他们的工作职责； Supervise and manage subordinates to ensure strict compliance with the provisions of the documents and properly fulfill their job responsibilities. 15

支持公司新的/改建的生产厂房或实验室项目（质量审核设计图纸、参与项目等）； Support the company's new / renovated production plant or laboratory project (quality audit design drawings, participate in projects, etc.). 16

支持公司各功能团队建立和健全无菌控制策略； Support the establishment and improvement of aseptic control strategies for all functional teams in the company. 17

负责部门人员绩效约定与考核，确保部门工作得到持续改进； Responsible for department personnel performance agreements and assessments to ensure continuous improvement of departmental work. 18

遵守公司各项管理制度，强化学习业务知识； Comply with all company management systems and strengthen learning of business knowledge. 19

完成上级领导交办的其他任务。 Completing other tasks assigned by the supervisor.

教育背景： Education background: 制药、生物制药、制药工程、生物、应用化学, 化学/药物分析或相关专业本科学历以上。 Bachelor degree or above in Pharmaceuticals, biopharmaceuticals, pharmaceutical engineering, biology, applied chemistry, chemistry/pharmaceutical analysis or related majors. 工作经验： Work experience: （GxP work experience is required for GxP related activities） 8年以上制药公司生产、质量管理工作经验，丰富的中美欧GMP认证及审计经验（有生物药或无菌产品生产质量管理工作经验优先） With over 8 years of experience in pharmaceutical production and quality management, rich experience in GMP certification and auditing in China, the United States, and Europe (experience in biopharmaceutical or aseptic product production quality management is preferred). 能力与技能： Ability and skills: 良好的英文读写能力，熟悉国内外GxP法规。 Good English reading and writing skills, familiar with domestic and foreign GxP regulations. 个性与品质： Behavior and quality: 责任心强；做事客观、严谨负责、踏实、敬业；良好的职业道德；团队合作精神；具有良好的学习能力和心理素质。 Strong sense of responsibility; Objective, rigorous, responsible, steadfast, dedicated; Good professional ethics; Spirit of teamwork; Good learning ability and psychological quality.