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Manager, QC&Lab [Pharma]
2-3万
人 · 本科 · 5年及以上工作经验 · 性别不限2024/11/22发布
五险一金年终奖金定期体检餐饮补贴节日福利带薪年假周末双休免费班车补充医疗保险

苏州工业园区

低价好房出租>>

东旺路2号

公司信息
阿普塔(中国)投资有限公司

外资(欧美)/1000-5000人

该公司所有职位
职位描述
This position aims to enhance local Pharma quality organization as well as to lead continual improvement and assuring the compliance of quality control practices against Aptar pharma procedures as well as applicable regulations.

Primary Duties and Responsibilities
86 Lead pharma QC team including QC lab (perform chemical, microbiological, functional control as well as routine clean environment monitoring) to achieve various KPIs
86 Introduce best practice(Risk-based Approach etc.) in QC dept to improve overall working efficiency as well as assuring GMP compliance
86 Develop young talents , build a strong and sustainable QC team to support pharma business development
86 Lead gap analysis of exposure drafts (related to packaging material) of CP2025 collaborating with RA and Scientific dept , implement associated actions within due date.
86 Maintain local bunding registration standard as well as SOPs related to QC dept according to CP2025 and GMP requirements.
86 Support Internal/External customer in terms of Quality Specification, Control Method; Conduct YBB study for sister company to support their product bundling registration.
86 QC lab method (re)validation and QC instrument (re)qualification per USP 1058
86 Support qualification for new project and product
86 Other tasks assigned by manager.

Required Qualifications
86 Bachelor’s degree or above with Chemistry or Pharmacy related majors.
86 More than 5 years’ experience in laboratory work (chemical analysis is preferable) and lab project introduction or transfer.
86 Familiar with ICH, CP and GLP
86 Good communication skills in both Chinese and English.
86 Outgoing, self-motivated, and creative thinker.

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