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Formulation QA Facilitator

Location Wuxi, Jiangsu, China Job ID R-073957 Date posted 05/12/2020

Responsibilities:

  • 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 fulfill 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
  • Additional requirement for Authorized Release QA Engineer
  • Release GF and CMO products
  • To maintain a smooth product release procedure
  • When take charge of the docs/samples archivist role: Ensure each team can follow document/sample archiving rooms’ procedures to conduct any archiving activities; Ensure each team record all the activities and keep the proper track of docs/samples
  • Draft, review and approve document to make sure in compliance with GMP requirement
  • Annual product review
  • Own QA procedure, secure operation GMP compliance
  • Lead and execute Change Control
  • Quality continuous improvement
  • Provide Coaching for peer and team member to handle QA affairs
  • 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 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, 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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Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.