DP Associate Director or Director

面议

武汉市

刷新时间：2023-06-21

职位描述

Job Responsibilities/岗位职责
1. Participate and provide leadership for the daily activities of the Drug Product Manufacturing Group. Accomplishes department objectives by supervising staff; organizing and monitoring work process;
参与并领导制剂生产团队的日常活动；指导员工完成部门目标；组织和监督工作进度；
2. Completes operations by developing schedules; assigning and monitoring work; gathering resources; implementing productivity standards; resolving operations problems; maintaining reference manuals; implementing new procedures;
通过制定计划表；分配和监控工作；收集资源；贯彻生产力标准；解决操作问题；维护参考手册；实施新程序来完成操作；
3. Controls expenses by gathering and submitting budget information; scheduling expenditures;monitoring variances; implementing corrective actions;
通过收集和提交预算信息，安排开支，监控差异，实施纠正措施等来控制开支；
4. Lead the activities of technology transfer, including techniques and documentation;
领导技术转移，包括技术和文件；
5. Lead troubleshooting efforts to resolve complex process and equipment issues;
领导故障排除工作，解决复杂的工艺和设备问题；
6. Train other specialists in group and individually on cGMP best practices, safety practices and compliance to QA-controlled documents, such as SOPs, Batch records;
从团队和个人层面对组员进行培训，包括 cGMP 最佳操作，安全操作和 QA 管控文件的合规性，例如 SOPs 和批生产记录；
7. Author documents for drug product manufacturing processes, review documentation and checkall calculations (eg batch records, labels equipment readings);
撰写制剂生产的工艺文件；审核文件并检查所有的计算（例如批记录，标签设备读数等）；
8. Provide input to QA on GMP facility issues and maintain oversight of the Environmental
Monitoring and Validation programs;
为 QA 提供有关 GMP 设施问题的意见，并对环境监测和验证计划进行监督；
9. Assist Manufacturing Manager in hosting regulatory or due diligence inspections. Act as SME to regulatory agencies as required. Oversee the timely response and follow-up to any observations;

协助生产经理主持法规或尽职调查检查，按要求充当监管机构的 SME 角色，监督对任何观察的及时反应和后续行动；

10. Participate in the internal auditing program as required. Anticipate potential problems and take preventative actions and escalate process issues as necessary to ensure resolution;
根据需要参与内部审计，预测潜在问题并采取预防措施，必要时上报流程问题，以确保问题得到解决；
11. Serve as a departmental representative on cross-functional teams.
担任跨职能团队的部门代表。
Job Requirements/岗位要求
1. The degree should be in a biological or engineering discipline (Biotechnology, Biochemistry,Chemical/Biochemical Engineering, or equivalent), at least 8 years’ experience for fill/finish inpharmaceutical industry;
本科及以上学历，生物技术、生物化学、化学、生物化学工程或相关专业，具有至少八年以上制药行业灌装工作经验；
2. Technical understanding with aseptic manufacturing process and working knowledge of GMPmanufacturing and regulatory principles and requirements;
具备对无菌生产工艺的技术理解，以及 GMP 生产、监管原则和要求等工作知识；
3. Experienced in aseptic drug product manufacturing, preferably protein drug;
具备无菌成品药生产经验，具备蛋白质药品生产经验者优先考虑；
4. Capable of writing detailed reports and summaries and exhibit detail oriented documentationskills;
能够编写详细的报告和总结，掌握良好的文档处理技术；
5. Communicate effectively and work professionally in a team environment;
能够在团队中进行有效沟通和专业工作；
6. Skilled in the use of computers and automation-drive equipment.
熟练使用计算机和自动化驱动设备；
7. Must be flexible to work on any shift (day, night, weekend) and able to work prolong duration onyour feet.
必须适应灵活的工作班次（白班、夜班、周末），接受加班；
8. Good oral and written communication skills in English and Mandarin (Read, Write, Verbal)demonstrated by communicating with other functions and management regarding resolvinginvestigations and theory.
需要有良好的中英文口头和书面交流能力（阅读、写作、口语）与其他职能部门和管理层就问题解决调查和理论进行沟通。

其他要求

招聘人数：1人
职能类别：药物制剂

公司介绍

诗迈医药猎头是一家专业从事医药行业猎头服务的科技型企业，总部位于杭州，下属有上海、南京、广州、武汉等多家分公司，同时自主开发国内领先的猎头办公系统及医药人才网站，全面致力于海内外制药、生物、医疗、器械等行业线上线下人力资源整合。
公司与全国各地研发企业、生产企业及销售经营等企业及业内同行建立了良好互动平台，在欧、美、日等国家建立了海归引进平台，同时积极开展医药高等院校公益系列讲座，搭建了以人力、企业为主体的立体化咨询服务网，为医药企业人才队伍建设发挥了积极重要作用，为很多医药企业解决了高端人力之困。