制剂生产负责人

35-45万元/年

泰州市

刷新时间：4天前

职位描述

1、负责生产活动，以实现现场生产目标。
2、确保产品的生产、储存和发货符合适当的文件标准。
3、批准生产操作规程（SOP、批处理和包装记录）并确保其严格执行。
4、确保生产记录在送交品质保证部之前，由授权人员进行评估和签署。
5、评估产品、工艺或设备的变更，并确保进行适当的验证。
6、指导批次故障、市场投诉和产品召回的调查工作。
7、确保生产作业按cGMP规定进行。
8、确保对部门人员进行必要的初始和持续培训。
9、通过维护和提高设备/机器的利用率来维持优良设备综合效率。
10、确保定期进行校准和预防性维护。
11、结合周工作要求，协调生产计划的合规性。
12、与QA，QC和仓库合作，执行计划的生产计划。
13、监督原材料、包装材料和成品仓库的相关活动。
14、参与供应商资格认证过程，并在必要时参与供应商审核。
15、确保工厂卫生，包括清洁和卫生。
16、确保工厂安全、健康和环境政策要求的执行。
17、配合采购团队进行在线物料采购和库存管理。
18、支持人力资源计划，以提高生产力和人才参与度 。
To be responsible for manufacturing activities in order to achieve production OTIF targets for the site
To ensure that products are produced, stored and despatched in line with appropriate documentation criteria
To approve the instructions relating to production operations (SOPs, Batch processing and packaging records) and ensure their strict implementation
To ensure that production records are ****uated and signed by authorized person before they are sent to Quality Assurance department.
To ****uate proposed changes in product, process or equipment and ensure that appropriate validations are done.
To guide in the investigation of Batch failures, Market complaints and Product recalls.
To ensure that the production operations are carried out as per cGMP regulations.
To ensure that required initial and continuing training of the department personnel are carried out
To maintain healthy OEE by maintaining and improving equipment/machine utilization
To ensure that calibrations and preventive maintenance are done at regular intervals
To coordinate with PPIC regarding compliance of production schedule
To collaborate with QA, QC and stores for implementation of planned production schedule.
To monitor the activities related to raw material, packing material and finished goods stores.
To participate in vendor qualification process and also in vendor audits, wherever necessary.
To ensure that plant hygiene including cleaning and sanitation are performed and maintained.
To ensure the implementation of Safety, Health and Environment policy requirements in the plant.
To coordinate with Procurement team for on line material procurement and inventory Management其他信息  

其他要求

招聘人数：1人
职能类别：生产技术员

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。