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Location:
Wuxi, Jiangsu, China
Job reference: R-042495
Posted date: Jan. 10, 2019
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Responsibilities:

- Handling, investigation and assessing of quality issues

- Establish, execute and track CAPA

- To be involved in regulatory inspections and self-inspection

- Ensure to fulfil the KPIs of QA

- Identify the quality risk during daily work, improve continuously

- Support PET business processes regarding compliance and quality

- Communicate with other AZ sites regarding to quality issues

- Coach team member managing QA affairs

- Review production sheet and release product

- Maintain a smooth product release procedure

- Returned goods handling

- To take part in vendor audit

- Draft and review document to make sure in compliance with GMP requirement

- Annual product review

- Own QA procedure, section operation GMP compliance

- Lead and execute Change Control

- Quality continuous improvement

- Lead daily QA work in Packing QA Team

- Work instruction and help to team members

- Build and develop team capability

- Provide daily performance feedback to team members

- SHE responsibilities

Requirements:

- University graduate, major in pharmaceutical or related subjects

- 5 years plus experience as quality assurance

- Good GMP and quality system management knowledge

- Knowledge of product process and typical equipment

- Knowledge of process control methodology and statistics, for example Cpk, FMEA

- Working knowledge of Microsoft applications, SAP or similar system

- Good English

- Good Computer skill

- Good communication skills, proactive leadership, strong quality minds and strong service minds

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Assistant Engineer, QA
QA

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