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QA Specialists

  • Sector: Science & Pharma
  • Contact: Aisling Lane
  • Contact Email: aisling.lane@collinsmcnicholas.ie
  • Job Ref: 17887

This multinational Pharmaceutical organisation is going through exciting growth in their Cork site. They are looking for 2 X QA Specialists to join their expanding team on a permanent basis.

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

  • Perform the role of key QA representative for assigned products (intermediate and API).
  • QA Review & Approval of Manufacturing Batch Records.
  • Use of Process Explorer IP21 to trend Quality Critical Parameters for Drug Substance and Intermediates..
  • Carry out QA review of product process deviations on an ongoing basis. to review the data for any recurring deviations.
  • Co-ordinate deviation notifications and ensure that these are closed out within appropriate timelines
  • Ensure appropriate investigations are performed on all deviations.
  • 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. 
  • Participate in GMP Audits.

What the ideal candidate looks like:

  • Relevant qualification such as BSc; masters or PhD in chemistry or related field.
  • Previous experience in Quality Assurance in API manufacturing environment is preferred.

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.

aisling.lane@collinsmcnicholas.ie

(021) 4320675