職位描述
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
