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Senior QA Specialist

  • Sector: Science & Pharma
  • Contact: Aisling Lane
  • Contact Email:
  • Job Ref: 17886

This multinational Pharmaceutical organisation is going through exciting growth in its Cork site. They are looking for a Senior QA Specialist to join their expanding team on a permanent basis.

Overview of Main Responsibilities (full job description available on request):

  • Support established products and new product introduction from a QA perspective.
  • Coordinate interface between QA, Operations, and Process Development Services.
  • Manage and prioritize activities of Quality Assurance Group such that customer/business, team, and individual objectives are met.
  • Work with customers to design and approve Quality Agreements in line with customer and site requirements.
  • Prepare and support the site for external/internal audits and Participate in level 1 & 2 audits as appropriate.
  • Perform Quality Assurance SME role for Local Change Control Panels.
  • QA Review & Approval of Manufacturing Batch Records.
  • Report any non-compliances to the QA manager and participate in any subsequent investigation, as appropriate.
  • Participate in Process Deviation & Root Cause Analysis Review.
  • Coordinate deviation notifications and ensure that these are closed out within appropriate timelines.
  • Support Implementation and maintenance of Process Deviation Management (PDM) for products.
  • Perform API Batch Release.
  • Ensure QA approval of original/revised manufacturing batch records (MBR's) and archival of historic documents.
  • Issue/approve COAs in compliance with customer requirements for each batch exported from the site.
  • Where appropriate assist in the investigation/reporting of customer complaints.
  • Participate in the authoring of Annual Product Reviews for the various products made on site.
  • Carry out timely validation of Drug Substance analytical test results.
  • Review and sign off any Laboratory Investigation Reports (LIR) associated with validated batches.

What the ideal candidate looks like:

  • Relevant qualifications such as BSc; master's or Ph.D. in chemistry or related field.
  • Previous experience in Quality Assurance in API manufacturing environment or related field is essential.
  • Line management/coaching / mentoring experience would be an advantage.

What you will get in return:

  • Competitive salary.
  • Bonus.
  • Pension.
  • Private medical insurance.
  • Free onsite parking.

For a confidential discussion and more information on the role, please contact Aisling Lane.

(021) 4320675