Head of QA Compliance
诺华疫苗中国（浙江天元生物药业有限公司）
- 公司行业：制药/生物工程
职位信息
- 发布日期：2014-07-17
- 工作地点：杭州
- 招聘人数：1
- 学历要求：本科
- 职位月薪：面议
- 职位类别：质量管理/测试经理(QA/QC经理)
职位描述
General (organization chart to be attached)
职位信息（部门架构附后）
Job Title
该职位名称 Head o QA Compliance
汇报对象 （职位名称）Head of QO
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）
Ensure all GMP systems and operations in Tianyuan comply with market authorization, relevant regulation, GMP requirements, Novartis quality standards and company procedures.
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. Together with the Manufacturing Head of QO for TY, provide direction and assist with formulating strategies and making decisions that ensure the efficient operation of the business as a whole;
2. Ensure products comply with market authorization and GMP requirements and advocate continuous improvement during manufacturing, distribution and shelf life, both for products manufactured at the TY manufacturing site and for Third Party products managed by the TY manufacturing site;
3. Ensure all quality systems, such as quality standard, supplier management, inspection management, documentation management, training management and change management conforms to Novartis and company standards in accordance with the phase determined in the Quality Master Plan, the local law and the laws and regulations of the countries where the product is sold;
4. Ensure all necessary qualification and validations are completed. Ensure that a high quality of products is achieved through qualification and validation based upon quality risk analysis;
5. Quality oversight on the manufacturing of pre-clinical and clinical materials.
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. No Compliance issue impact product release
2. No critical observation from HA inspection in any GXP inspection. Or Novartis audits
3. Control the overdue compliance activities under predefined limits
4. Control costs and personnel budget
Job Dimensions (Indicate key facts and figures)
角色范围(主要关键因素)
Number of associates下属人数:10
Financial responsibility财务职责:Maintain the department cost within the approved budget.
(Budget预算, Cost成本, Sales销售, etc.)
Key business partner主要工作联络部门: Health Authority, TechOps, Marketing, TD
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:
Bachelor degree in the field of Microbiology, Chemistry, Biology or other appropriate education and experience in pharmaceutical industry
Minimum Education:最低教育:
Bachelor degree
Desired Education: 有以下教育经验更佳:
Master degree.
Languages所需语言:
Language语言 Spoken 口语 Written书写 Read阅读
English英语 fluent fluent fluent
Chinese中文 fluent fluent fluent
Experience工作经验:
10 years working experience in sterile product or vaccine product, related quality management experience both in quality assurance and quality control area. Multinational experience is required.
Minimum 最低要求 :
8 years working experience in sterile product or vaccine product, related quality management experience in quality assurance..
Desired 有以下经验更佳:
10 years management experience.
Skills (e.g. IT)) 工作技能 (如IT技能等) ：
Good skills for Microsoft software
职位信息（部门架构附后）
Job Title
该职位名称 Head o QA Compliance
汇报对象 （职位名称）Head of QO
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）
Ensure all GMP systems and operations in Tianyuan comply with market authorization, relevant regulation, GMP requirements, Novartis quality standards and company procedures.
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. Together with the Manufacturing Head of QO for TY, provide direction and assist with formulating strategies and making decisions that ensure the efficient operation of the business as a whole;
2. Ensure products comply with market authorization and GMP requirements and advocate continuous improvement during manufacturing, distribution and shelf life, both for products manufactured at the TY manufacturing site and for Third Party products managed by the TY manufacturing site;
3. Ensure all quality systems, such as quality standard, supplier management, inspection management, documentation management, training management and change management conforms to Novartis and company standards in accordance with the phase determined in the Quality Master Plan, the local law and the laws and regulations of the countries where the product is sold;
4. Ensure all necessary qualification and validations are completed. Ensure that a high quality of products is achieved through qualification and validation based upon quality risk analysis;
5. Quality oversight on the manufacturing of pre-clinical and clinical materials.
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. No Compliance issue impact product release
2. No critical observation from HA inspection in any GXP inspection. Or Novartis audits
3. Control the overdue compliance activities under predefined limits
4. Control costs and personnel budget
Job Dimensions (Indicate key facts and figures)
角色范围(主要关键因素)
Number of associates下属人数:10
Financial responsibility财务职责:Maintain the department cost within the approved budget.
(Budget预算, Cost成本, Sales销售, etc.)
Key business partner主要工作联络部门: Health Authority, TechOps, Marketing, TD
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:
Bachelor degree in the field of Microbiology, Chemistry, Biology or other appropriate education and experience in pharmaceutical industry
Minimum Education:最低教育:
Bachelor degree
Desired Education: 有以下教育经验更佳:
Master degree.
Languages所需语言:
Language语言 Spoken 口语 Written书写 Read阅读
English英语 fluent fluent fluent
Chinese中文 fluent fluent fluent
Experience工作经验:
10 years working experience in sterile product or vaccine product, related quality management experience both in quality assurance and quality control area. Multinational experience is required.
Minimum 最低要求 :
8 years working experience in sterile product or vaccine product, related quality management experience in quality assurance..
Desired 有以下经验更佳:
10 years management experience.
Skills (e.g. IT)) 工作技能 (如IT技能等) ：
Good skills for Microsoft software
公司介绍
诺华疫苗中国（浙江天元生物药业有限公司）诚聘
联系方式
- Email：assistant.hr@novartis.com.cn