QA现场监督
浙江天元生物药业有限公司
- 公司性质：合资(欧美)
- 公司行业：制药/生物工程
职位信息
- 发布日期：2013-09-18
- 工作地点：杭州-余杭区
- 招聘人数：若干
- 工作经验：三年以上
- 学历要求：本科
- 语言要求：英语良好
- 职位类别：生物工程/生物制药 其他
职位描述
Job Purpose (State in one sentence the overall objective of the role)
职位设定的目的 （用一语句描述该职位的总的工作目标）
Responsible for workshop working procedure production process each routine supervision, select examination, review the product batch records, timely response and solve problem, make sure all aspects of the laws and regulations in accordance with GMP requirements and applicable Novartis quality manual requirements. Responsible for materials release work, ensure Disposition Material no potential quality problems.
负责车间各工序生产过程日常监督、抽查，审核产品批记录，及时反映问题，调查解决问题，确保所有方面符合GMP的法律法规的要求和公司的管理操作标准要求。负责完成物料确保放行无聊无潜在质量问题。
Major Accountabilities (Describe the 5-7 main results of the role to be achieved)
主要职责内容（5-7个主要职责）
1. Responsible for workshop working procedure production process each routine supervision, selective examination, to ensure production process controllable and press standards implementation.
负责车间各工序生产过程日常监督、抽查，确保生产过程可控并按标准执行。
2. Coordinate production with problems, deviation and reject reports etc, investigation, supervision and correction.
协调生产过程中出现的问题、偏差及不合格品等报告、调查，监督纠正。
3. Responsible for materials inspection check, Batch record audit Material printed and issued certificate.
负责物料送检核对，批记录审核，无聊合格证打印及发放。
4. Be responsible for reviewing finished product batch records, ensure batch record is complete, no potential quality problems.
负责审核成品批记录，确保批记录齐全、无潜在质量问题。
5. Responsible for products Outer packing materials Version update Before printing of check and the new version release to Old version of Recovery work.
负责产品外包装材料版本更新印制前的核对及新版本发布时对旧版本的回收工作。
6. Collect information about the production process quality of the quality control, the paper summarizes and analyses the work for improvement.
收集生产过程有关质量信息，对质量控制工作情况进行总结与分析，加以改进。
7. According to New Quality system requirements related assessment improvement, review and revised Related SOP and Master batch record.
根据新质量体系要求进行相关审核评估改进，并审核修订相关SOP及主批记录。
8. Assist department to work, complete the temporary task issued at a higher level.
协助完成部门工作以及上级下达的各项临时任务。
Key Performance Indicators (Indicate how performance for this role will be measured)
KPI绩效指标(绩效目标主要衡量指标)
1. Competent group work task within the timeliness主管组内工作任务完成及时性
2. Responsible for complete Material release Related working 负责完成物料放行相关工作
3. Competent group as the quality of work completed within 主管组内工作认为的完成质量
4. Competent in the group work efficiency 主管组内工作效率
5. Work coordination 工作协调性
6. Dealing with problems timeliness and comprehensive 问题处理及时性及周全性
7. External coordination 外部评价
8. Attendance 出勤率
Job Dimensions (Indicate key facts and figures)
角色范围(主要关键因素)
Number of associates下属人数:
Financial responsibility财务职责:
(Budget预算, Cost成本, Sales销售, etc.)
Key business partner主要工作联络部门: Quality, production, Engineering,logistic,validation
质量、生产、工程、供应、验证
Ideal Background (State the preferred education and experience level)
教育及工作经验相关要求
Education (minimum/desirable) 教育: University Degree in the field of Microbiology, Chemistry ,Biotechnology ,or Pharmacy (BSc or MSc from accredited Technical University preferred) or other appropriate education and experience in pharmaceutical industry
大学以上学历，微生物学、化学、生物技术、生物化学或制药（正规技术大学优先考虑）或其他适当的教育和经验在生物技术和制药行业。
Minimum Education:最低教育:Bachelor degree
Desired Education: 有以下教育经验更佳: Science or Administration related.
Languages所需语言
Language语言 Spoken 口语 Written书写 Read阅读
English英语 good good good
Chinese中文 Good Good Good
Experience工作经验: Over 1 year relevant working experience.
Minimum 最低要求 : As above
职位设定的目的 （用一语句描述该职位的总的工作目标）
Responsible for workshop working procedure production process each routine supervision, select examination, review the product batch records, timely response and solve problem, make sure all aspects of the laws and regulations in accordance with GMP requirements and applicable Novartis quality manual requirements. Responsible for materials release work, ensure Disposition Material no potential quality problems.
负责车间各工序生产过程日常监督、抽查，审核产品批记录，及时反映问题，调查解决问题，确保所有方面符合GMP的法律法规的要求和公司的管理操作标准要求。负责完成物料确保放行无聊无潜在质量问题。
Major Accountabilities (Describe the 5-7 main results of the role to be achieved)
主要职责内容（5-7个主要职责）
1. Responsible for workshop working procedure production process each routine supervision, selective examination, to ensure production process controllable and press standards implementation.
负责车间各工序生产过程日常监督、抽查，确保生产过程可控并按标准执行。
2. Coordinate production with problems, deviation and reject reports etc, investigation, supervision and correction.
协调生产过程中出现的问题、偏差及不合格品等报告、调查，监督纠正。
3. Responsible for materials inspection check, Batch record audit Material printed and issued certificate.
负责物料送检核对，批记录审核，无聊合格证打印及发放。
4. Be responsible for reviewing finished product batch records, ensure batch record is complete, no potential quality problems.
负责审核成品批记录，确保批记录齐全、无潜在质量问题。
5. Responsible for products Outer packing materials Version update Before printing of check and the new version release to Old version of Recovery work.
负责产品外包装材料版本更新印制前的核对及新版本发布时对旧版本的回收工作。
6. Collect information about the production process quality of the quality control, the paper summarizes and analyses the work for improvement.
收集生产过程有关质量信息，对质量控制工作情况进行总结与分析，加以改进。
7. According to New Quality system requirements related assessment improvement, review and revised Related SOP and Master batch record.
根据新质量体系要求进行相关审核评估改进，并审核修订相关SOP及主批记录。
8. Assist department to work, complete the temporary task issued at a higher level.
协助完成部门工作以及上级下达的各项临时任务。
Key Performance Indicators (Indicate how performance for this role will be measured)
KPI绩效指标(绩效目标主要衡量指标)
1. Competent group work task within the timeliness主管组内工作任务完成及时性
2. Responsible for complete Material release Related working 负责完成物料放行相关工作
3. Competent group as the quality of work completed within 主管组内工作认为的完成质量
4. Competent in the group work efficiency 主管组内工作效率
5. Work coordination 工作协调性
6. Dealing with problems timeliness and comprehensive 问题处理及时性及周全性
7. External coordination 外部评价
8. Attendance 出勤率
Job Dimensions (Indicate key facts and figures)
角色范围(主要关键因素)
Number of associates下属人数:
Financial responsibility财务职责:
(Budget预算, Cost成本, Sales销售, etc.)
Key business partner主要工作联络部门: Quality, production, Engineering,logistic,validation
质量、生产、工程、供应、验证
Ideal Background (State the preferred education and experience level)
教育及工作经验相关要求
Education (minimum/desirable) 教育: University Degree in the field of Microbiology, Chemistry ,Biotechnology ,or Pharmacy (BSc or MSc from accredited Technical University preferred) or other appropriate education and experience in pharmaceutical industry
大学以上学历，微生物学、化学、生物技术、生物化学或制药（正规技术大学优先考虑）或其他适当的教育和经验在生物技术和制药行业。
Minimum Education:最低教育:Bachelor degree
Desired Education: 有以下教育经验更佳: Science or Administration related.
Languages所需语言
Language语言 Spoken 口语 Written书写 Read阅读
English英语 good good good
Chinese中文 Good Good Good
Experience工作经验: Over 1 year relevant working experience.
Minimum 最低要求 : As above
公司介绍
浙江天元生物药业有限公司 诚聘
联系方式
- 公司地址：杭州市余杭经济开发区天荷路56号 (邮编：311100)