Senior QA Specialist
3d ago


  • Work as part of an experienced QA team involved in day to day operational QA activities in support of manufacturing
  • Set long term objectives and work with senior management to deliver KPIs related to quality across site
  • With support from the employer undertake training and development in key areas of expertise to gain the ability to act as site subject matter expert
  • Play a key role in aspects of Regulatory and customer audits
  • Participate actively or lead in deviation investigations, change controls, CAPA plans
  • Ensure adherence to site SOP’s and policies and act as champion within QA and manufacturing.
  • A competent Reviewer and Approver of SOPs, protocols, reports or records.
  • Lead a small team and provides supervision to QA Coordinators, interns or Specialists.
  • Requirements :

  • Bachelor’s degree in a relevant scientific subject
  • At least 5 years’ experience of working in QA
  • Experience of managing or supervising small teams with QA / Operations is highly desirable
  • Knowledge of working in a sterile / aseptic biopharma manufacturing environment is highly desirable.
  • Experience in leading quality focused projects in a manufacturing environment such as CAPA, deviation, ROOT Cause analysis projects will be essential for success in this role
  • Knowledge of lean / six sigma as part of a GMP environment will be desirable
  • Apply
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