Quality Assurance Technician

Job description


About Your New Employer

  • World leading Biopharma company, currently ranked in the Top 5 Biopharma companies globally.
  • In Ireland, our client has been recognised as the Pharma Industry Company of the Year and is listed in the top 3 Best Large Workplaces in Ireland.
  • You will be based in a state-of-the-art site which is a strategic facility in the global network.

About Your New Job

  • Perform assigned task in accordance with procedural requirements and scheduled timelines. Notify supervisor and other impacted stakeholders if procedural requirements or timelines are not being met.
  • Understand cGMPs and procedural requirements for your area of responsibility and be a resource to operators and other personnel to ensure compliance to these requirements.
  • Assess and understand events that may not be in accordance with procedures or cGMPs. Make decisions consistent with job responsibilities, regulations and Allergan procedures and policies.  Provide appropriate comments to cGMPs documents, when needed.  Provide timely feedback and details to supervision and other impacted personnel.
  • Perform routine review of documentation generated by personnel such as BMRs, logbooks, forms, protocols, reports, COAs, etc. generated to support commercial and development products for accuracy, completeness, and compliance to GMP and procedural requirements.
  • Author documents that ensure cGMP compliance, such as Standard Operating Procedures, investigations, reports and forms.
  • Monitor documentation errors and work with personnel to correct documentation, as needed, and develop preventive actions to reduce or eliminate recurrences.
  • Draft, review, and approve qualification documentation for production equipment.
  • Draft, review and approve cleaning validation protocols and reports.
  • Draft, review and approve Product Quality Reviews.
  • Draft, review, and approve SOPs, Site Master Files, forms, and other documentation, as required. Track and publish review schedules.  Follow-up with authors, reviewers and approvers to assure review schedules are met.
  • Initiate, facilitate, monitor, trend Change Control, Complaints, Deviations, CAPAs and other Quality System documents as required.

What Skills You Need

  • BSc Degree in Chemistry or Life Science degree preferred.
  • Prior pharmaceutical or quality assurance experience
  • Knowledge of cGMP requirements and practices preferred.
  • Strong analytical skills and knowledge of quality systems.

What’s on Offer

  • Permanent position with world leading Biopharma company
  • Competitive base salary
  • Pension
  • Annual Bonus
  • Healthcare

What’s Next​

  • Apply now by clicking the “Apply Now" button or call me, Ryan Malone on +353 86 7718408.​

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