职责描述： 1.Ensure that all production personnel are appropriately trained for their positions. 确保所有生产人员接受合理岗位培训。 2. Always must Supervise all the activities for the Lyophilization an d Packaging process. 必须一直监管冻干和包装工艺的所有活动。 3.Ensure all activities are executed in compliance with the Quality Management System along with SOPs Batch Records log Protocols cGMP. 确保按照质量管理体系，SOPs批记录，日志，协议，cGMP执行所有活动。 4.When required participate in the Weekly Operations Organization Meetings 应需要参加周运营组织会议 5.Assist with the scheduling of equipment systems calibration an d systems preventative maintenance. 协助设备系统校准和系统预防性维护的计划表。 6.Assist with the tracking equipment systems uptime availability faults an d failures process yields an d reject data. 协助追踪设备系统正常运行，错误和故障，工艺成品率和不合格数据。 7.Responsble for the development of personnel with technical mentorship. 负责发展员工并给予技术指导。 8.Assist management with accurate personnel yearly assessment. 协助管理层人员年度评估。 9.Write review an d approve SOPs required by area. 撰写，审查和批准区域要求的SOPs。 10.Daily reporting of all activities critical quality compliance issues to manufacturing management effectively an d timely communication. 日常报告所有的活动，关键质量合规问题到生产管理层并及时和有效沟通。 11.Responsible for reviewing product batch production records ensuring the batch records are complete accurately an d correctly. 负责审核生产的批生产记录，确保准确完成批记录。 12.Perform risk management risk review meetings failure investigations. 进行风险管理风险审查会议，失效调查。 13.Assist with the manufacturing activities for new product development. 协助新产品开发的生产活动。 14.Production Plan according to ensure the Process Changeover Line Clearance are appropriate 生产计划确保工艺变化生产线清场合理。 任职要求： 1. Minimum of 3-6 years of Pharmaceutical experience establishing implementing refining an d manufacturing activities.. 至少3- -6年制药行业，建立，执行，改善和运营生产活动的经验。 2.Proven track record managing manufacturing activities. 可靠的生产工艺管理的工作业绩。 3.Knowledge of FDA ISO EMA GMP an d ICH quality systems regulatory. FDA、ISO、EMA、GMP和ICH质量体系、法规方面的知识。 4.Minimum a technical degree in computer an d electronic engineering Pharmacy chemistry andor biology. 至少具有计算机、电子工程、制药、化学和或生物学的技术职称。 技能： 1. Excellent organizational communication an d interpersonal skills. 良好的组织、沟通和人际交往能力。 2. Strong analytical an d leadership skills. 强大的分析和领导能力。 3. Problem analysis an d problem solving experience. 问题分析和问题解决经验。 4. Planning an d organizing. 计划和组织能力。 5. Good Judgment an d decision making. 良好的判断和决策能力。 6. Ability to work independently. 能够独立完成工作。 7. Outstanding organizational skills. 出色的组织能力。 8. Ability to operate in a fast-paced multi-disciplinary industrial environment. 能够操作一个快节奏的、多学科的工业环境。 9. Understanding an d proficiency on managing software programs such as Words PowerPoint an d Excel. 了解并熟练使用管理软件如Words PowerPoint an d Excel。