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Sr. QA Engineer

Ort Taizhou, Jiangsu Sheng, China Anzeigen-ID R-113767 Veröffentlichungsdatum 07/13/2021

Purpose

To establish and sustain a culture of Quality Assurance and Regulatory Compliance that is proactive and professional that meets regulatory requirements, adds value, satisfies customer expectations and delivers a competitive advantage to the business.

Responsibilities:

  • Quality systems management
  • Creating and maintenance quality management system procedure for BM manufacturing procedure
  • Investigation of quality issues
  • Deviation and CAPA management
  • Change control management
  • To be involved in the self-inspection

  • Validation documents  
  • Review qualification and validation documents.
  • Review production sheet
  • Responsible for solving the quality issues with operation team.
  • Raw material and product release     
  • If authorized, take responsibility for bulk product, API, excipients and packing materials releas
  • Responsible for assessment of returned goods
  • handling of returned goods and rejected goods

  • Management of QA affairs  
  • Ensure to fulfill the KPIs of QA
  • Quality continuous improvement
  • Annual product review
  • Product complaint and handling of returned goods
  • SHE responsibilities

Requirements

  • University graduate, major in pharmaceutical or related subjects
  • 5 years plus experience as quality assurance or quality control roles in the Pharmaceutical Industry, MNC background preferred
  • Good GMP and quality system management knowledge, and pharmaceutical knowledge
  • Working knowledge of regulatory agency interactions and compliance procedures, with ability to apply the knowledge in an operations environment
  • Knowledge of Process control & capability methodology, for example Cpk, FMEA
  • Have taken the role of supplier management QA/material QA/production QA or other related QA work.


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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