Quality Assurance Specialist – 11‑month hybrid contract

About the role

We are seeking a Quality Assurance Specialist to join our client’s site in Carlow on an 11‑month hybrid contract. The role provides QA oversight across analytical, warehouse and facilities functions while supporting new product and material introductions.

Key responsibilities

• Provide QA oversight for analytical, warehouse and facilities management, including deviations, root‑cause analysis, CAPAs and change controls.
• Act as functional expert in cross‑functional teams introducing new products and materials.
• Review and approve documentation such as material packs, QC test specifications, BOMs and supplier qualification records.
• Develop, monitor and report supplier performance metrics; participate in material review boards and quarterly supplier reviews.
• Maintain the approved supplier management list in the qualified Supplier Management system.
• Support deviation close‑out, initiate and follow up on corrective and preventive actions.
• Author, review and approve protocols and reports for technology transfer, method qualification and validation.
• Conduct quality reviews of engineering, validation, automation and utilities commissioning activities.
• Serve as the primary quality contact for the site and external parties, coordinating quality working‑group meetings.
• Facilitate compliance with divisional policies, guidelines and regulatory requirements, and drive major compliance initiatives.

Required profile

• 3‑5 years of experience in a quality role within pharmaceutical manufacturing.
• Knowledge of Irish, European and international regulatory codes and standards.
• Familiarity with cGMP and GDP practices.
• Strong report, standards and policy writing abilities.
• Experience with equipment and process validation, including sterile filling processes.
• Proficiency in Microsoft Office and related computer applications.
• Experience or familiarity with Lean Six Sigma methodology.
• Ability to work independently, drive task completion and make decisions with moderate guidance.

Required skills

• cGMP
• GDP
• Equipment validation
• Process validation
• Sterile filling processes
• Microsoft Office
• Lean Six Sigma