QC Supervisor
Animal Health-上海诺华动物保健有限公司
- 公司规模:150-500人
- 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:2013-11-06
- 工作地点:上海-奉贤区
- 招聘人数:1
- 工作经验:五年以上
- 学历要求:本科
- 职位类别:质量管理/测试主管(QA/QC主管)
职位描述
Major Accountabilities (Describe the main results of the job to be achieved )
1. Lead the QC team while embodying the principles of the Novartis Global Leadership standard.
2. Schedule and/or delivers training to QC personnel in accordance with Training Plans to ensure staff can perform assigned tasks correctly, safely and compliantly.
3. Review SOPs, coordinate method development and ensures concurrency with cGMP regulations and requirements.
4. Coordinate and support validation, engineering and production assignment according to manufacturing schedule without compromising quality.
5. Oversees sampling and laboratory testing execution to produce results in timely manner without compromising quality.
6. Responsible for the documentation and investigation of laboratory deviations, errors, and out of specifications/out of tolerance results.
7. Analyze Environmental Monitoring and Water Systems data and write trending reports.
8. Implement analytical method validation and QC instrument qualification including CSV activities in QC field.
9. Ensure QC Lab safety and Personnel Protective Equipment is used in the laboratory area.
Key Performance Indicators (Indicate how performance will be measured: indicators, activities…)
1. Performs in accordance with departmental objectives and Novartis standards.
2. Successful outcome of internal and external inspections.
3. Timely testing and release of materials.
4. Timely communication and support about product/project specific quality issues
provided to QA and related customers (e.g. chemist) and meet key milestones.
5. Feedback from supervisors, chemists, department managers and site manager.
Job Dimensions (Indicate key facts and figures)
Number of Associates:
Up to 7 direct or indirect reports
Financial responsibility
(where appropriate):
Adhere to established budget.
Impact on the organisation
(where appropriate): Support Wusi site by providing QC expertise, procedures and processes. Enhance quality reputation
of Novartis through external industry contacts.
Contribute to the skills of associates. Errors would
result in failure to achieve major goals and objectives
of the organization and financial loss.
Ideal Background (State the minimum and desirable education and experience level)
Education: Minimum: BS degree in Chemistry, Pharmacy or relevant discipline
Desirable: MS or equivalent
Languages: CET 4, Fluent English (oral and written) required
Experience:
1. BS with at least 10 years of experience or MS with at least 5 years QC experience in pharmaceutical or relevant industry.
2. Demonstrated laboratory skills in analytical methods like Titrator, FTIR, UV, GC and HPLC, etc. is highly desirable.
3. Prior experience in analytical support role for bulk process(API) and formulation is a plus.
4. Be able to effectively partner with diverse team members from various functions and at various levels in organization.
5. Good and detailed knowledge of cGMPs.
6. Familiar with Microsoft Word and Excel.
1. Lead the QC team while embodying the principles of the Novartis Global Leadership standard.
2. Schedule and/or delivers training to QC personnel in accordance with Training Plans to ensure staff can perform assigned tasks correctly, safely and compliantly.
3. Review SOPs, coordinate method development and ensures concurrency with cGMP regulations and requirements.
4. Coordinate and support validation, engineering and production assignment according to manufacturing schedule without compromising quality.
5. Oversees sampling and laboratory testing execution to produce results in timely manner without compromising quality.
6. Responsible for the documentation and investigation of laboratory deviations, errors, and out of specifications/out of tolerance results.
7. Analyze Environmental Monitoring and Water Systems data and write trending reports.
8. Implement analytical method validation and QC instrument qualification including CSV activities in QC field.
9. Ensure QC Lab safety and Personnel Protective Equipment is used in the laboratory area.
Key Performance Indicators (Indicate how performance will be measured: indicators, activities…)
1. Performs in accordance with departmental objectives and Novartis standards.
2. Successful outcome of internal and external inspections.
3. Timely testing and release of materials.
4. Timely communication and support about product/project specific quality issues
provided to QA and related customers (e.g. chemist) and meet key milestones.
5. Feedback from supervisors, chemists, department managers and site manager.
Job Dimensions (Indicate key facts and figures)
Number of Associates:
Up to 7 direct or indirect reports
Financial responsibility
(where appropriate):
Adhere to established budget.
Impact on the organisation
(where appropriate): Support Wusi site by providing QC expertise, procedures and processes. Enhance quality reputation
of Novartis through external industry contacts.
Contribute to the skills of associates. Errors would
result in failure to achieve major goals and objectives
of the organization and financial loss.
Ideal Background (State the minimum and desirable education and experience level)
Education: Minimum: BS degree in Chemistry, Pharmacy or relevant discipline
Desirable: MS or equivalent
Languages: CET 4, Fluent English (oral and written) required
Experience:
1. BS with at least 10 years of experience or MS with at least 5 years QC experience in pharmaceutical or relevant industry.
2. Demonstrated laboratory skills in analytical methods like Titrator, FTIR, UV, GC and HPLC, etc. is highly desirable.
3. Prior experience in analytical support role for bulk process(API) and formulation is a plus.
4. Be able to effectively partner with diverse team members from various functions and at various levels in organization.
5. Good and detailed knowledge of cGMPs.
6. Familiar with Microsoft Word and Excel.
公司介绍
Shanghai Novartis Animal Health Co., Ltd. (SNAH) is a joint venture invested by Novartis Group (Switzerland) and it's China partners. SNAH was established in 1990 with total investment of .CHF50 million. Headquarter of SNAH locates in Shanghai, and it's 39,000m2 affiliated manufacturing plant is in Wusi Farm, Fengxian County. The production lines were formally launched in 1994.
Shanghai Novartis Animal Health Co., Ltd. is the first animal health enterprise been awarded with GMP certificate by Minister of Agricultural in China. SNAH introduces advanced production line, equipment and know-how to manufacture, formulate and repack animal health products. With our complete quality control system, the products are guaranteed to meet both local and international standards. Our products supply to domestic market, and also export to South East Asia, Australia, Africa, Europe, etc. Most of them are re-sale to Switzerland.
For more information please visit our website.
We are committed to build sustainable competitive advantage through the quality, capability and performance of our people. We are currently looking for:
Novartis will provide attractive salary package, benefit and career development opportunities.
Interested candidates please send your CV both in English and Chinese, current and expected salary to us and write the position title on the envelope.
Shanghai Novartis Animal Health Co., Ltd. is the first animal health enterprise been awarded with GMP certificate by Minister of Agricultural in China. SNAH introduces advanced production line, equipment and know-how to manufacture, formulate and repack animal health products. With our complete quality control system, the products are guaranteed to meet both local and international standards. Our products supply to domestic market, and also export to South East Asia, Australia, Africa, Europe, etc. Most of them are re-sale to Switzerland.
For more information please visit our website.
We are committed to build sustainable competitive advantage through the quality, capability and performance of our people. We are currently looking for:
Novartis will provide attractive salary package, benefit and career development opportunities.
Interested candidates please send your CV both in English and Chinese, current and expected salary to us and write the position title on the envelope.
联系方式
- 公司网站:http://www.novartis.com.cn
- 公司地址:上海市长乐路989号世纪商贸广场1601室上海诺华动物保健有限公司人力资源部(请注明应聘职位及信息来源渠道)
- 邮政编码:200031
- 联系人:人力资源部
- 传真:021-54049987