GMP制剂生产ED

面议

宁波市

刷新时间：2023-07-18

职位描述

  职位描述

1.     教育背景和任职资格EDUCATION BACKGROUND and QUALIFICATION

1.1.     应当至少具有药学或相关专业本科学历（或中级专业技术职称或执业药师资格）。

Bachelor degree or above in pharmacy or related majors (or intermediate professional technical title or licensed pharmacist qualification).

1.2.     具有至少五年从事药品生产和质量管理的实践经验，其中至少有三年的药品生产管理经验。

At least five years of experience in drug product manufacturing and quality management, including at least three year of experience in drug production management.

1.3.     了解相关制药法规，如《****共和国药品管理法》和GMP法规。

Understand the relevant pharmaceutical laws and regulations, such as “The Drug Administration Law of

the PRC” and “Good Manufacturing Practices”.

1.4.     熟悉产品的工艺过程、SOP、质量控制点，掌握关键设备的性能和操作。

Familiar with the product process, SOP, quality control point, master the performance and operation of

key equipment.

1.5.     具有工艺问题分析能力、设计方案能力、判断能力、操作能力、与他人沟通能力。

Have ability to analyze process problems, design protocols, judge, operate and communicate with others.

1.6.     具有与生产相关其它部门的管理能力，如库房、设备和清洁验证等。

Have ability to manage the other departments related to manufacturing, such as warehouse, equipment and cleaning validation.

1.7.     具有独立解决产品工艺问题的能力。

Have ability to solve process problems independently.

1.8.     接受过与所生产产品相关的专业知识培训。

Have received professional knowledge training related to the products produced.

1.9.     具有一定的英语能力，应能与国外客户进行有效的沟通。

Have a certain English ability, and should be able to communicate effectively with foreign ******s.

 

2.     工作内容CONTENT

2.1.     审核产品工艺试制方案和报告。

Review the study protocol and report for the process of drug product.

2.2.     审核工艺验证方案和报告。

Review the validation protocol and report for the production process.

2.3.     审核和批准生产计划。

Review and approve the schedule of manufacturing.

2.4.     审核制剂生产工艺规程。

Review the process procedure for the production of drug product.

2.5.     按照已批准的生产工艺规程进行药品的生产。

Produce DP according to approved instructions for the production of drug product.

2.6.     审核所有的批生产记录，确保记录完整并已签名。

Review all production batch records and ensure that these are completed and signed.

2.7.     调查和评估生产偏差，并上报QA。

Investigate and evaluate the production deviations, and report to QA.

2.8.     确保所有的生产偏差都已报告、评估，关键的偏差已作了调查，并记录了结论。

Make sure that all production deviations are reported and evaluated and that critical deviations are investigated and the conclusions are recorded.

2.9.     确保生产设施是清洁的，并在必要时消毒。

Make sure that production facilities are clean and when appropriate disinfected.

2.10.   确保进行必要的校验，并有记录。

Make sure that the necessary calibrations are performed and records kept.

2.11.   确保厂房和设备的维护保养，并有记录。

Make sure that the facilities and equipment are maintained and records kept.

2.12.   确保验证方案和报告的审核与批准。

Make sure that validation protocols and reports are reviewed and approved.

2.13.   对产品、工艺或设备的变更做出评估。

Evaluate proposed changes in product, process or equipment.

2.14.   确保新的或经过改造的（必要时）生产设施设备和库房通过确认。

Make sure that new and, when appropriate, modified facilities, equipment and warehouse are qualified.

2.15.   完成其他相关工作。

Execute other related tasks.

其他要求

招聘人数：1人
职能类别：生产经理

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。