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.