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Packing QA Engineer

Plats Wuxi, Jiangsu Sheng, Kina Jobb-id R-056915 Datum inlagd 07/26/2019

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



AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

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