QA Specialist- Pharma | Collins McNicholas

QA Specialist- Pharma

  • Reference: AJ42740
  • Job Type: Permanent
  • Location: Galway, Offaly, Westmeath
  • Category: Bio-Pharmaceutical

Our Client, a specialist pharmaceutical manufacturer has a requirement for a suitably qualified and experienced QA Specialist on a 6 month fixed term contract for their manufacturing facility in Athlone.

QA Specialist responsibilities:

  • Ensuring the effective operation of QMS processes, specifically maintenance of Quality records
  • Acting as a point of contact for representatives of other functional areas for queries regarding the QMS
  • Generation and/or revision of QMS Standard Operating Procedures (SOPs)
  • Reviewing and approving other SOPs (e.g. Production, Engineering, QC) and documents (e.g. Specifications, Master Batch Records)
  • Providing oversight of internal compliance with SOPs, logbooks and general GMP to ensure audit readiness
  • Reviewing and approving records which are part of the QMS (which may include, but is not limited to: Batch Records, QC data, Validation data)
  • Preparing batch records for QP review and approval
  • Participate in the team for internal and third party audits

QA Specialist will have:

  • BSc/MSc in science discipline required
  • Experience working in finished product pharmaceutical / biologics, including analytical chemistry, quality assurance, quality control, development, and /or manufacturing areas is essential
  • QC analytical experience desirable
  • Good knowledge of quality systems, FDA and EU GMP regulations and ICH guidelines.

For a confidential discussion and a more detailed job description (or more information on the role), please contact Tina Egan on 09064 78104or email

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Tina Egan

Contact Consultant

  • Tina Egan
  • Recruitment Consultant
  • 09064 50663
  • Connect with Tina

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