Associate Quality Director
2.2-2.8万·13薪
 苏州-苏州工业园区
 1年及以上
 本科
 中文、传播学
 全职
 更新于03-12
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职位信息

KEY RESPONSIBILITIES:
1. Lead and direct all aspects of quality function, develop and implement Quality Strategy according to the internal regulation and external law.
2. Act as primary interface representing QA in intra company and client/customer interactions.
3.Accountable for the establishment or the functional quality organizational design for QA/QC.
4.Implement corporate Quality Management Systems aligned with Eminence strategic and corporate objectives spanning the following areas:
61Facilities & Equipment
61Laboratory Controls
61Material Controls
61Production Controls
61Packaging & Labelling
5.Provide cross functional support to internal Eminence departments to ensure sustainability and continuous improvement in all compliance and quality functions.
6.Implement and lead of the Quality Management Review committee.
7.Closely work with other department and client for China and US/EU IND and other clinical phases application submission.
8.Commercial Management
9.Representing the company to external parties with focus on GMP compliance.
10.Recruiting and management of Quality staff.
11.Selecting, approval, and management of preferred contract service providers in partnership with Engineering and Facilities to perform supplement internal capabilities and capacity.
12.Preparing budget and management of expenditure in line with budget for Quality functions and activities.
13. Other tasks assigned by superior.
QUALIFICATIONS:
1.Bachelor's degree or above,Chemical, pharmaceutical, biology related majors.
2.Thorough knowledge of GLP and GMP encompassing documentation and operation of pharmaceutical facilities.
3.Detailed knowledge in the design, implementation and maintenance of Quality Management Systems for global compliance.
4.Experience in managing QA/QC team and cross-function team.
5.Ability to investigate and solve complex technical problems.
6.Excellent communication skills in Chinese and English to engage with personnel from multiple disciplines and experience bases across the operations organization.
工作地址
 建屋紫金东方
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公司信息
关于艾米能斯
成立于2016年,艾米能斯专注细胞培养基领域,致力于为客户提供优质的CHO细胞和化学限定培养基产品,以及稳定细胞株构建和培养基配方定制化开发等全面服务。艾米能斯开发了拥有自主知识产权的CHO细胞培养基配方库,在此基础上研发并上市了适用于包括CHO-K1、CHO-S、CHO-DG44等细胞系的EmCD CHO 基础培养基和 EmCD CHO Feed补料培养基。此外,针对常用的商业化宿主细胞如CHOZN,ExpiCHO-S和HEK293,艾米能斯开发了相应的用于稳定表达或瞬时表达的培养基,从而满足客户对于细胞培养基的个性化需求。
艾米能斯已建立了符合GMP要求和ISO认证的培养基生产工厂及质量体系,可以确保为客户提供批间稳定和持续的产品供应。
About Eminence
Founded in 2016, Eminence is dedicated to supplying life science companies with best-in-class media, including CHO cells (Chinese Hamster Ovary) and other chemically-defined media products, as well as custom cell-line and media formulation development services. Based on its proprietary formulation pool for CHO culture media, Eminence has developed EmCD CHO basal medium and EmCD CHO Feed for CHO-K1, CHO-S, CHO-DG44. In addition, Eminence offers a series of cell culture media for CHOZN, ExpiCHO-S and HEK293 cells to cater to customers' diverse needs.
Eminence's quality system and facilities are ISO-certified and GMP-compliant to ensure batch-to-batch consistency and stability of the delivered products.
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