作者 |
QA/RA manager-猎头职位 |
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Belinda Chen
头衔: 海归少校
加入时间: 2010/03/01 文章: 71
海归分: 11790
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作者:Belinda Chen 在 海归招聘 发贴, 来自【海归网】 http://www.haiguinet.com
Job duty:
1.ensuring that quality system requirements are effectively established, 2.implemented and maintained.
3.reporting on the performance of the quality system to management with executive responsibility for review and any need for improvement.
4.ensuring the promotion of awareness of regulatory and customer requirements throughout the organization.
Handling of internal / external audits.
5.Conduct periodic Management Review.
6.Manage the quality aspect of QC, including microbiology lab.
7. ‘Quality’ responsibility in connection with procurement and purchasing of raw materials. Supplier management and evaluation.
8.Product sterility assurance.
9.Approval of transferred/new products from Ambu A/S.
10.Approval of outsourcing/local sourcing activities.
11.Support and review local R&D activities in terms of QA Engineering.
12.In charge of all local regulatory affairs and assist Corporate RA in other international regulatory affairs and product registration.
13.Establish and manage the Calibration Program for monitoring and measuring devices.
Responsibility:
1.Possess at least Bachelor’s Degree in any science discipline (Microbiology background preferred)
2.Qualified/certified Lead Auditor
3.Sound knowledge in ISO 9001, ISO 13485, 21 CFR 820, 21 CFR 11, Chinese GMP, ISO 11137, ISO 11135, ISO 11737
4.Good analytical skills
5.Sound knowledge in process validation and risk management
6.Excellent communication skills in Chinese and English
7.An expert in sterilization technology and requirements (gamma, ethylene oxide and electron beam)
8.Overseas work experience
作者:Belinda Chen 在 海归招聘 发贴, 来自【海归网】 http://www.haiguinet.com
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- QA/RA manager-猎头职位 -- Belinda Chen - (1612 Byte) 2015-8-19 周三, 15:06 (1703 reads)
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