新建医药包装行业招聘QC Mgr/Supervisor
北京外企德科人力资源服务上海有限公司
- 公司规模:10000人以上
- 公司性质:合资(欧美)
- 公司行业:专业服务(咨询、人力资源、财会)
职位信息
- 发布日期:2014-05-29
- 工作地点:苏州
- 招聘人数:若干
- 工作经验:五年以上
- 学历要求:本科
- 语言要求:英语熟练
- 职位月薪:面议
- 职位类别:质量管理/测试主管(QA/QC主管)
职位描述
职位描述:
QC Manager/Supervisor
Major Accountabilities
1. Demonstrated QC experience as well as leadership skills in lab.
2. Mentor, coach and train lab personnel, to ensure that the required initial and continuing training of lab personnel is carried out and adapted according to need.
3. Ensure adequate planning of routine lab testing and other testing activities (e.g. stability, investigations)
4. Participation in establishment, implementation and maintenance of the quality system in lab, and to strengthen lab quality systems and processes continually.
5. Management of the Site OOS and Stability Committee.
6. Authorize written procedures and other documents which related to QC lab.
7. Approve or reject starting materials, packaging materials, and intermediate, bulk product in relation with their specification
8. To ensure the adequate facilities, trained personnel and approved procedures must be available for sampling, inspecting, and testing starting materials, packaging materials, intermediate, bulk, finished products, and where appropriate for monitoring environmental conditions for GMP purposed.
9. To ensure the samples of starting materials, packaging materials, intermediate products, bulk products and finished products must be taken by methods and personnel approved.
10. To ensure that the necessary and relevant tests are actually carried out. The materials are not released for use and no products are released from QC, until their quality has been judged to be satisfactory.
11. To ensure the records must be made demonstrating that all the required sampling, inspecting and testing procedures have actually been carried out and that any deviations have been fully recorded and investigated.
12. To ensure the records must be made of the results of inspecting and testing against specifications; product assessment must include a review and evaluation of the relevant production documentation and an assessment of deviations from specified procedures.
13. To ensure the sufficient samples of starting materials and products must be retained to permit future examination of the product if necessary; the retained product must be kept in property.
14. To establish, validate and implement all QC procedures in lab (e.g. sampling instructions, specifications, test methods and other QC procedures)
15. Technical support for in-process controls lab.
16. To participate in the investigation of complaints related to the quality of the product,
17. To ensure the maintenance /qualification /calibration of control instrument in lab are carried out.
18. To ensure the reference standards were evaluated, maintained, stored and used in lab.
19. To ensure all the QC operations should be carried out in accordance with written procedures and in compliance.
20. Participation in environment monitoring in site.
21. Participation in validation program.
22. Participation the regular internal audits or self –inspections.
23. Participation in external audit if necessary (contract lab);
24. Ensure health & safety procedures are followed i,e. near miss accidents, workstation assessment etc.
Requirement
1. Education: BS/MS in Analytical Chemistry/ Pharmaceutical Chemistry/Chemistry/ or related discipline.
2. Languages: Fluent English and Chinese
3. Minimum 5 years’ experience in a regulated pharmaceutical/medical laboratory.
4. Strong communication skill, interacting with people from interface functions in the local and global Novartis network as well as regulatory bodies.
5. Customer oriented and collaboration with local regulatory bodies and other Novartis sites as well as global functions.
QC Manager/Supervisor
Major Accountabilities
1. Demonstrated QC experience as well as leadership skills in lab.
2. Mentor, coach and train lab personnel, to ensure that the required initial and continuing training of lab personnel is carried out and adapted according to need.
3. Ensure adequate planning of routine lab testing and other testing activities (e.g. stability, investigations)
4. Participation in establishment, implementation and maintenance of the quality system in lab, and to strengthen lab quality systems and processes continually.
5. Management of the Site OOS and Stability Committee.
6. Authorize written procedures and other documents which related to QC lab.
7. Approve or reject starting materials, packaging materials, and intermediate, bulk product in relation with their specification
8. To ensure the adequate facilities, trained personnel and approved procedures must be available for sampling, inspecting, and testing starting materials, packaging materials, intermediate, bulk, finished products, and where appropriate for monitoring environmental conditions for GMP purposed.
9. To ensure the samples of starting materials, packaging materials, intermediate products, bulk products and finished products must be taken by methods and personnel approved.
10. To ensure that the necessary and relevant tests are actually carried out. The materials are not released for use and no products are released from QC, until their quality has been judged to be satisfactory.
11. To ensure the records must be made demonstrating that all the required sampling, inspecting and testing procedures have actually been carried out and that any deviations have been fully recorded and investigated.
12. To ensure the records must be made of the results of inspecting and testing against specifications; product assessment must include a review and evaluation of the relevant production documentation and an assessment of deviations from specified procedures.
13. To ensure the sufficient samples of starting materials and products must be retained to permit future examination of the product if necessary; the retained product must be kept in property.
14. To establish, validate and implement all QC procedures in lab (e.g. sampling instructions, specifications, test methods and other QC procedures)
15. Technical support for in-process controls lab.
16. To participate in the investigation of complaints related to the quality of the product,
17. To ensure the maintenance /qualification /calibration of control instrument in lab are carried out.
18. To ensure the reference standards were evaluated, maintained, stored and used in lab.
19. To ensure all the QC operations should be carried out in accordance with written procedures and in compliance.
20. Participation in environment monitoring in site.
21. Participation in validation program.
22. Participation the regular internal audits or self –inspections.
23. Participation in external audit if necessary (contract lab);
24. Ensure health & safety procedures are followed i,e. near miss accidents, workstation assessment etc.
Requirement
1. Education: BS/MS in Analytical Chemistry/ Pharmaceutical Chemistry/Chemistry/ or related discipline.
2. Languages: Fluent English and Chinese
3. Minimum 5 years’ experience in a regulated pharmaceutical/medical laboratory.
4. Strong communication skill, interacting with people from interface functions in the local and global Novartis network as well as regulatory bodies.
5. Customer oriented and collaboration with local regulatory bodies and other Novartis sites as well as global functions.
公司介绍
北京外企德科人力资源服务上海有限公司(简称 FESCO Adecco 外企德科)是中国人力资源服务行业具竞争力和品牌价值的FESCO与全球人力资源服务行业领航者Adecco成立的一家中外合资人力资源服务企业,为企业及个人提供业务外包、人事服务、招聘猎头和员工福利等相关人力资源解决方案。
成立于1979年,FESCO拥有悠久的人力资源专业化服务历史、丰富的市场经验以及完备的服务资质,是中国人力资源服务行业的领跑者,Adecco则是全球人力资源行业的巨头,服务网络遍布全球60多个国家和地区。FESCO Adecco成立后,双方通过优势互补,整合了客户资源,依托全球化的资源和服务平台,融合本土网络优势,扩大了业务范围,为客户提供全方位的业务流程外包(BPO)、财务外包与薪酬管理、人事委托/人事派遣、全球化派遣、人才招聘/RPO相关服务、健康福利与弹性福利等人力资源解决方案。合资后的FESCO Adecco飞速发展,并且在浙江、重庆、深圳、苏州设立了分支机构。目前,FESCO Adecco在中国每天服务达100万名员工,服务客户近12,000家。
FESCO Adecco致力于成为***的人力资源全面解决方案提供商,成为客户最值得信赖的人力资源合作伙伴。为客户打开通向国际市场及创新型人力资源服务模式的大门,推动中国乃至全球的人力资源外包产业的健康发展。
成立于1979年,FESCO拥有悠久的人力资源专业化服务历史、丰富的市场经验以及完备的服务资质,是中国人力资源服务行业的领跑者,Adecco则是全球人力资源行业的巨头,服务网络遍布全球60多个国家和地区。FESCO Adecco成立后,双方通过优势互补,整合了客户资源,依托全球化的资源和服务平台,融合本土网络优势,扩大了业务范围,为客户提供全方位的业务流程外包(BPO)、财务外包与薪酬管理、人事委托/人事派遣、全球化派遣、人才招聘/RPO相关服务、健康福利与弹性福利等人力资源解决方案。合资后的FESCO Adecco飞速发展,并且在浙江、重庆、深圳、苏州设立了分支机构。目前,FESCO Adecco在中国每天服务达100万名员工,服务客户近12,000家。
FESCO Adecco致力于成为***的人力资源全面解决方案提供商,成为客户最值得信赖的人力资源合作伙伴。为客户打开通向国际市场及创新型人力资源服务模式的大门,推动中国乃至全球的人力资源外包产业的健康发展。
联系方式
- Email:recruitment@circassia.com
- 公司地址:天目西路128号嘉里不夜城企业中心***座19楼