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质量总监
2-3万·15薪
人 · 本科 · 10年及以上工作经验 · 性别不限2024/11/12发布
五险一金餐饮补贴年终奖金

苏州工业园区

低价好房出租>>

桑田岛生物产业园二期C区24号楼

公司信息
艾米能斯(苏州)生物科技有限公司

外资(欧美)/50-150人

该公司所有职位
职位描述
职位描述:
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.
职位要求:
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.Excellent communication skills in Chinese and English to engage with personnel from multiple disciplines and experience bases across the operations organization.

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