生物/制药 工作职责： 1.负责内审及外审管理和协调,协调审计会议,审核审计相关文件的完整性、合规性、确保审计产生的CAPA制定清晰。
Responsible for internal audit and external audit management and coordination, coordinating audit meetings, reviewing the integrity and compliance of audit-related documents to ensure clear formulation of CAPA resulting from audits. 2.负责审计产生CAPA行动的定期追踪并答复客户相关CAPA的完成情况,负责定期回顾审计相关质量指标。
Responsible for the periodic tracking of CAPA actions arising from audits and for responding to customers regarding the completion status of relevant CAPAs; responsible for the periodic review of audit-related quality metrics. 3.负责CAPA流程的总体管理和协调,审核CAPA的合理性、完整性和合规性,负责定期回顾CAPA管理质量指标。
Responsible for overall management and coordination of the CAPA process, review the reasonableness, completeness, and compliance of CAPA, and responsible for regular review of CAPA management quality indicators. 4.负责质量风险总体管理和协调,负责风险降低措施的定期跟踪,负责组织进行风险回顾和评价,负责定期回顾质量风险相关质量指标。
Responsible for overall quality risk management and coordination, responsible for regular tracking of risk reduction measures, responsible for organizing risk reviews and evaluations, and responsible for regularly reviewing quality risk-related quality indicators. 5.完成上级领导交待的其他工作任务。
Complete the other tasks assigned by the superior. 任职资格 1.教育背景：本科及以上制药、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。
Education background: Undergraduate and above in pharmaceuticals, biopharmaceuticals, pharmaceutical engineering, biology, applied chemistry, chemistry/drug analysis or related majors. 2.工作经验：3年及以上制药或生物药方面质量管理的工作经验。
Work experience: 3 years or more working experience in pharmaceutical or biopharmaceutical quality management.. 3.能力与技能：熟悉国内外GMP相关法律、法规和指导文件; 熟悉生物药生产基本流程。
Ability and skills: Familiar with domestic and foreign GMP-related laws, regulations, and guidance documents; Familiar with the basic process of biopharmaceutical production. 4.个性与品质：较强的原则性,较好的分析、解决问题能力，思路清晰，考虑问题细致。责任心强，做事客观、严谨负责。良好的团队合作精神，学习能力和心理素质，较强的沟通、协调能力。
Behavior and quality: Strong principles, good analytical and problem-solving abilities, clear thinking, careful consideration of issues. Strong sense of responsibility, objective, rigorous, and responsible work; good team spirit, learning ability, and psychological quality, strong communication and coordination skills