Formulation QA Assistant Engineer社
面议
无锡市本科及以上4年及以上
发布时间:2023-09-06
职位描述
Responsibilities:
- Onsite inspection, identify potential risk, help enhance the quality sense of the operator- Handling, investigation and assessing of quality issues- Establish, execute and track CAPA- Review batch production report- To be involved in regulatory inspections and self-inspection- Ensure to fulfil the KPIs of QA- Support PET business processes regarding compliance and quality- Identify the quality risk during daily work, improve continuously- Communicate with other AZ sites regarding to quality issues- Release GF and CMO products- To maintain a smooth product release procedure- Draft and review document to make sure in compliance with GMP requirement- Annual product review- Lead and execute Change Control- Quality continuous improvement- SHE responsibilities
Requirements:
- University graduate, major in pharmaceutical or related subjects- 3 years plus experience as quality assurance- Good GMP and quality system management knowledge- Knowledge of process control methodology and statistics, for example Cpk, FMEA- Knowledge of product process and typical equipment- Working knowledge of Microsoft applications, SAP or similar system- Good English- Good Computer skill- Good communication skills, strong quality minds and strong service minds
其他要求
-
1人
公司介绍
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