万兴服务 · R&D

External Clinical Supply Quality (Senior) Specialist-小分子

20k-30k/月  /  上海

昨天 10:18 更新

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职位属性

  • 招聘类型:社招
  • 工作性质:全职

职位描述

1.Document assessments of the quality systems for supply chain API, drug products, raw materials, components, packaging materials by means of on-site audits, questionnaires, or other tools.During these assessments the manufacturing processes of these materials will be evaluated and the reliability of executed tests and of data to be provided by the supplier will be judged;

2.Monitor the quality parameters for the suppliers and report their performance on regular basis.Evaluation of reported changes and define corrective actions if applicable including new qualifications.Assess the impact of reported quality deviations and changes on the status of the suppliers and linked materials and coordinate the required corrective actions. This can be lead to the szlection and qualification of new suppliers in cooperation with other departments;

3.Involvement in change management, risk assessment, deviations, escalations, compliance issues, recalls, field actions that are related to suppliers and the material they supply and/or external manufacturers of APIs and intermediates where applicable;

4.Establishment and periodic review of Quality Agreements;

5.Establishment and revision of Qualification Statements, periodic performance metrics, and qualification classification for suppliers;

6.Help in preparation for and during health authority inspections at JSC sites or suppliers, as needed;

7.Participate in partnership or improvement projects.

任职条件

1.Bachelor or above degree, major in medicine, chemistry, biology, science, or related fields;6-15 years of experience in pharmaceutical factory management;

2. Experience in QA and QC in pharmaceutical factories; Candidates with experience in pharmaceutical factory production and QA, and GMP compliance experience;

3. Background in small molecule API and DP quality .

公司福利

  • 六险一金
  • 带薪年假
  • 年终奖
  • 子女险
  • 带薪病假
  • 婚假
  • 陪产假
  • 生日礼品
  • 节日礼品
  • 13薪
  • 团建
  • 补充商业医疗保险