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QA Associate

QA Associate

Job description

About Your New Employer

My client is the world leader in delivering first-in-class therapies for rare genetic diseases.

They are now hiring a QA Associate to join their ever-growing team for a 23-month contract.

Operating across 4 continents they have an appetite for science, which drives them to provide life-changing results for their patients worldwide.

They have a skilled workforce that is collaborative, curious and shares a passion for shared accomplishments.

 

 About Your New Job

  • Provide QA support to the site for drug substance GMP operations (Warehouse/material operations, Upstream/Downstream and Support Services manufacturing, Automation and Process Engineering, MES, QA Validation and Capital Projects).
  • Review of MES Exceptions.
  • Support lot release activities/schedule including preparation of BDS/FBDS lot files.
  • Release of Raw Materials for drug substance production.
  • Review and approve deviations and QC LIR reports to ensure that root causes have been identified, appropriate corrective actions have been implemented and appropriate impact assessments are complete.
  • Review and approval of process and equipment validation/qualification protocols/reports.
  • Support and drive Continuous Improvement/Lean initiatives on site.

 

What Skills You Need

  • Level 8 honours degree Bachelor of Sciences (BSc) degree, or equivalent, in a technical discipline (physical, engineering, chemical or biological sciences, pharmacy) is required.
  • Minimum 3-5 years of relevant experience in a cGMP regulated manufacturing environment, with exhibited knowledge and proficiency in Quality Assurance and Regulatory Compliance.
  • Experience using MES, Trackwise and Veeva programmes. 
  • Demonstrated ability in problem-solving and experience in managing Root Cause Analysis / Non-Conformance /Deviation investigations.
  • Ability to coach junior QA staff.
  • Strong ability to communicate, make decisions, present data, and defend approaches in front of audiences and inspectors.
  • Experience with batch release activities is an advantage.

 

What’s on Offer

  • Full time – 39 hours p/w – 23-month contract.
  • Shift role - 6-week cycle including 1 week of earlies and 1 week of lates with 4 weeks of days. Earlies = 06:30am-14:30, lates = 14:30-22:30 (Friday 06:30am-13:30, 13:30-20:30)
  • 25 days annual leave.
  • Salaried – monthly paid.

What’s Next​

  • For a confidential discussion on this or any other current job opportunity please contact Meggan Tully on 087-7631660/mtully@sigmar.ie.

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