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QA Operations Specialist

QA Operations Specialist-Pharma-Dublin-Contract.

The Quality Specialist will provide direct Quality support to production and support areas as part of a Quality IPT (Integrated Product Team). You will perform a review of GMP documentation/data for accuracy, completeness, and data integrity compliance.

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

  • Participate as the quality member on cross-functional projects.

  • Responsible for review/approval of new and updated Master Batch Records / Electronic Batch Records.

  • Review executed production documentation such as electronic batch records and logbooks to ensure accuracy and compliance with cGMPs and company procedures and ensures completion of proper remediation of errors.

  • Provides presence on the shop floor to support compliance and data integrity.

  • Review & approve new and updated SOPs/ Work Instructions and Controlled Job Aides.

  • QA support, review and approval of Commissioning and Qualification lifecycle documents for capital projects and new equipment.

  • Will serve as the Quality SME for Performance qualification (PQ) & Process Validation activities across site.

  • Support sustaining activities such as Change Management, Deviations, CAPAs, Equipment Requalification, Periodic review, Site Maintenance & Calibration Programs.

  • Provides support to internal audits and regulatory inspections.

What the ideal candidate looks like:

  • Bachelor degree, in a scientific or engineering field (preferred)

  • Minimum 3 years of relevant post-degree work experience in GMP Manufacturing or Laboratory environment.

  • Experience in quality systems, pharmaceutical manufacturing or laboratory processes, authoring and approving GMP documents.

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

aisling.lane@collinsmcnicholas.ie

(021) 4320675