Quality Auditor/SQE(世界著名医药行业垄断公司,亚太区采购中心岗位,直接向欧洲总部汇报,市中心上班)
上海帝博企业管理咨询有限公司
- 公司规模：少于50人
- 公司性质：外资(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：2012-08-31
- 工作地点：上海
- 招聘人数：1
- 工作经验：五年以上
- 学历要求：本科
- 语言要求：英语熟练
- 职位类别：供应商管理 质量管理/测试工程师(QA/QC工程师)
职位描述
Quality Auditor/SQE(世界著名医药行业垄断公司，亚太区采购中心岗位，直接向欧洲总部汇报，丰厚的薪资福利和海外培训机会，市中心上班，欢迎制药/食品行业公司质量相关人员应聘)
JOB PROFILE
Location: Shanghai
Your responsibilities will include:-
To evaluate new suppliers by means of audit to establish technical ability to supply to the agreed Quality standards including finished products, components, raw materials and novel packaging where required.
To support the procurement department in providing technical and quality support to sourcing activities.
To collate information from suppliers covering starting materials, manufacture, testing, release and stability of each product and critically review for completeness and in conjunction with regulatory.
To review the supplied information against the relevant product specifications and product registration information and identify / resolve differences.
To liaise with the regulatory department to initiate changes to technical dossiers & product information packs where necessary & co-ordinate with relevant departments to generate supporting data where required.
To ensure audits are conducted as per the schedule for third party Suppliers on an ongoing basis.
To ensure that third party products are entered onto the stability Schedule as appropriate, or make provision with supplier, as appropriate.
To assist in the co-ordination of technical transfer to third party suppliers, including review and monitoring of transfer protocols, advising of stability requirements, or independent testing and monitoring the completion of product validation reports with NPD / Process support as necessary.
To liase with suppliers, acting as a point of contact for troubleshooting queries or authority to make changes (and whether changes will be acceptable to each country supplied).
To handle supplier non-conformances by liasing with supplier to organise corrective and preventative actions.
To ensure that Technical agreements are in place with all suppliers and that the terms and conditions contained therein are adhered to.
To conduct internal audits of functions and warehouse distribution as required.
Any other duty commensurate with the level and the role required to support the business needs.
The ideal applicant will have the following experience:-
Experienced QA professional with pharmaceutical background. Positive, flexible, pro-active approach
First Degree or equivalent in science based subject.
Trained, qualified (lead) auditor to ISO9001:2000 and ideally ISO13485 plus pharmaceutical GMP standards ( PICS guidelines / EU Rules and Guidance for pharmaceutical manufacturers and distributors 2007 and / or US FDA cGMPs)
Extensive experience of auditing external suppliers at particularly within Asia Pacific region to Pharmaceutical GMP, ISO 9001:2000 and ideally ISO13485 standards.
Fluent in English/ Mandarin
Excellent verbal & written communication skills
JOB PROFILE
Location: Shanghai
Your responsibilities will include:-
To evaluate new suppliers by means of audit to establish technical ability to supply to the agreed Quality standards including finished products, components, raw materials and novel packaging where required.
To support the procurement department in providing technical and quality support to sourcing activities.
To collate information from suppliers covering starting materials, manufacture, testing, release and stability of each product and critically review for completeness and in conjunction with regulatory.
To review the supplied information against the relevant product specifications and product registration information and identify / resolve differences.
To liaise with the regulatory department to initiate changes to technical dossiers & product information packs where necessary & co-ordinate with relevant departments to generate supporting data where required.
To ensure audits are conducted as per the schedule for third party Suppliers on an ongoing basis.
To ensure that third party products are entered onto the stability Schedule as appropriate, or make provision with supplier, as appropriate.
To assist in the co-ordination of technical transfer to third party suppliers, including review and monitoring of transfer protocols, advising of stability requirements, or independent testing and monitoring the completion of product validation reports with NPD / Process support as necessary.
To liase with suppliers, acting as a point of contact for troubleshooting queries or authority to make changes (and whether changes will be acceptable to each country supplied).
To handle supplier non-conformances by liasing with supplier to organise corrective and preventative actions.
To ensure that Technical agreements are in place with all suppliers and that the terms and conditions contained therein are adhered to.
To conduct internal audits of functions and warehouse distribution as required.
Any other duty commensurate with the level and the role required to support the business needs.
The ideal applicant will have the following experience:-
Experienced QA professional with pharmaceutical background. Positive, flexible, pro-active approach
First Degree or equivalent in science based subject.
Trained, qualified (lead) auditor to ISO9001:2000 and ideally ISO13485 plus pharmaceutical GMP standards ( PICS guidelines / EU Rules and Guidance for pharmaceutical manufacturers and distributors 2007 and / or US FDA cGMPs)
Extensive experience of auditing external suppliers at particularly within Asia Pacific region to Pharmaceutical GMP, ISO 9001:2000 and ideally ISO13485 standards.
Fluent in English/ Mandarin
Excellent verbal & written communication skills
In return, you will be working in a very friendly team environment with a long term personal development opportunity in a stable yet fast growing business environment. To apply please send resume to adz@db-talent.cn
公司介绍
公司微博：******************/dbtalent?ref=http%3A%2F%***********%2F2674989551%2Ffans%3Ftopnav%3D11
公司QQ：1652479807
公司msn：workdbtalent@hotmail.com
公司QQ：1652479807
公司msn：workdbtalent@hotmail.com
联系方式
- Email：workdbtalent@hotmail.com
- 电话：13701722965