Production GMP Engineer

Responsibilities

1.       生产管理Production work management

• 负责相关区域WI的编写，培训，监控和年度回顾Responsible for the writing, training, monitoring, and annual review of relevant regional Wis.
• 监督负责卫生情况和现场5S系统的管理和维持Supervise the management and maintenance of hygiene and on-site 5S.
• 确保负责的相关操作规程得到审核批准，并得到严格执行Ensure that responsible SOP are reviewed, approved, and strictly enforced.
• 配合GMP新产品的开发、转移及在产产品的工艺优化工Cooperate with the Technical Research Department to complete the development and transfer of GMP new products, as well as the optimization of the process for products in production.
• 负责制定GMP相关的改造文件的编写或者审核Responsible for developing or reviewing GMP related modification documents.
• 参与生产技术质量分析会，提倡合理化建议，降低产品成本Participate in production technology quality analysis meetings, advocate for rational suggestions, and reduce product costs.
• 定期审核关于本部门的投诉，聆听客户的意见Regularly review complaints about our department and listen to customer feedback.
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2.       安全生产Safety management

• 确保生产部在安全体系的引导下进行安全生产Ensure that the production department conducts safety production under the guidance of the safety system.
•  重视安全生产，并组织安全自查或与有关部门进行安全生产检查，发现问题及时采取各种有效措施，消除事故隐患Pay attention to safety production and organize safety self-inspection or conduct safety production inspections with relevant departments. If problems are found, take various effective measures in a timely manner to eliminate accident hazards.
• 配合安全环保部，落实工厂安全、环保、职业健康管理体系工作Cooperate with the Safety and Environmental Protection Department to implement the factory's safety, environmental protection, and occupational health management system work.
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3.       生产部GMP体系管理Quality control

• 确认负责的GMP相关记录填写完整并审核；负责相关GMP文件的编写，培训，执行，跟进和年度的回顾Confirm that the responsible GMP related records are completed and reviewed; Responsible for the preparation, training, execution, follow-up, and annual review of relevant GMP documents.
• 负责产品、工艺、设备、厂房等拟作的变更/验证，并监督实施Responsible for the proposed changes/verifications of products, processes, equipment, factories, etc., and supervising their implementation.
• 确保有及时有效的沟通机制和逐级汇报程序，将质量问题传递到适当的管理层Ensure timely and effective communication mechanisms and step-by-step reporting procedures are in place to convey quality issues to appropriate management levels.
• 识别并管理部门内部产生的风险，定期回顾、分析风险控制措施并不断改进Identify and manage internal risks within the department, regularly review and analyze risk control measures, and continuously improve them.
• 负责GMP相关设备的异常处理，偏差调查Responsible for abnormal handling and deviation investigation of GMP related equipment.