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Job Function:
Quality
Job Sub Function:
Quality Systems
Job Category:
Professional
All Job Posting Locations:
Xian, Shaanxi, China
Job Description:
- 实施内/外部GMP 审计，确保责任部门执行相关整改措施；根据GMP要求和评估结果改进质量体系；
- Perform internal and external GMP audit as a team member. Make sure the responsible dept. to implement related CAPA. Improve quality systems based on internal & external assessments to align with GMP requirements;
- 现场质量（GMP）管理，批记录审核，主数据批准；物料的处置和产品的就地行动决定；按照GMP 要求管理、监控剔除品和返回产品；上报；有效管理不符合事件，CAPA和变更实施；以确保产品安全，有效，均一。支持产品引进；
- Onsite GMP supervision, MBR review, master data approval, Make decision for products field action and materials disposition. Manage and monitor rejected and returned materials handling to meet GMP requirements. Escalation. Manage Non- conformance, CAPA closure and CoC execution, make sure products with safety, effective, and purity. Support product technical transfer;
- 依据强生IQP程序及GMP要求有效处理外部客户的质量投诉，满足客户潜在需求；支持并监控生产过程，指导相关人员按照程序的要求规范操作；
- Handle external customer quality complaint effectively aligned with J&J/IQP policy and GMP to meet & exceed customer potential requirements. Monitor and support production process, and instruct operator to follow procedure requirements;
- 依据程序和GMP要求，审核批准与GMP相关的程序，系统年度趋势报告及印字包材；
- Review and approve GMP related procedure and system annual trend report and art work to meet procedure and GMP requirements;
- 建立部门的安全、环境、工业卫生目标，培训并监督相关人员严格遵守执行；
- Establish department environmental, safety and industry hygiene objectives. Help organize sufficient training and site inspection to ensure all operations comply with environmental, safety and industry hygiene regulations and J&J requirements;
- 确保日常操作符合特殊药品安全管理制度及相关文件要求
- Ensure that daily operations comply with control substance safety management system and related document requirements.
- 组织制订安全管理文件，并指导、监督文件的执行。
- Organize the formulation of safety management documents, and guide and supervise the implementation of documents.
- 负责指导并监督特殊药品生产全过程的安全管理工作。
- Responsible for guiding and supervising the safety management of the whole process of production of control substance.
- 组织开展安全管理教育和培训。
- Organize safety management education and training.
- 负责异常情况和安全事件的调查、处理及报告。
- Responsible for the investigation, handling and reporting of anomalies and security incidents.
- 组织实施安全管理体系的自检，并对安全风险管理措施的有效性进行评估。Organize the implementation of safety management system self-inspection and evaluate the effectiveness of safety risk management measures
- 其他上级领导分配的任务；Other assigned tasks from line managers;
Required Skills:
Preferred Skills:
Agility Jumps, Analytical Reasoning, Analytics Dashboards, Coaching, Collaborating, Communication, Compliance Management, Data Compilation, Data Quality, Data Savvy, Document Management, Problem Solving, Quality Auditing, Quality Control (QC), Quality Management Systems (QMS), Quality Services, Quality Standards, System Audits, Systems Analysis
