QA Specialist

Orion Group Life Sciences are currently recruiting a Quality Assurance Specialist on behalf of our Multinational Pharmaceutical client based in Carlow on an initial 11-month contract with strong potential to extend.
 

• Hybrid (1–3 days per week onsite)

 
Role Overview
This role provides quality oversight and direction for the introduction of new products and materials and the management of external parties. The Quality Assurance Specialist supports compliance activities across Analytical, Warehouse, and Facilities Management functions, ensuring alignment with regulatory, quality, and company standards.
 
Key Responsibilities

• Provide QA oversight for new product and material introductions.
• Support Analytical, Warehouse, and Facilities teams with deviations, root cause analysis, CAPAs, and change controls.
• Act as a QA representative on cross-functional teams introducing new products and materials.
• Review and approve documentation such as Material Packs, QC Test Specifications, Bills of Materials, and Supplier Qualification records.
• Develop and track supplier performance metrics, participate in supplier reviews, and maintain the approved supplier list.
• Manage supplier and material setups in the Qualified Supplier Management System.
• Lead or support deviation investigations and corrective/preventive actions.
• Author, review, and approve validation protocols and reports (technology transfer, method qualification/validation).
• Perform quality reviews of engineering, validation, automation, and utilities commissioning and qualification.
• Serve as a site point of contact for QA-related matters and external quality interactions.
• Ensure compliance with internal and regulatory standards, identifying and implementing improvement opportunities.
• Participate actively in site and quality committees and cross-functional improvement initiatives.

 
Experience and Skills

• 3–5 years’ experience in a quality role, ideally within pharmaceutical manufacturing.
• Strong understanding of regulatory and code requirements (Irish, European, and international).
• Working knowledge of cGMP and GDP.
• Skilled in writing reports, standards, and policies.
• Experience in equipment and process validation.
• Familiarity with sterile manufacturing and filling processes.
• Proficient in Microsoft Office and related software.
• Experience with Lean Six Sigma principles (desirable).
• Strong collaboration and teamworking skills.
• Ability to work independently and take initiative.
• Solid decision-making and accountability mindset.
• Strong problem-solving and analytical skills.

 
Qualifications

• Bachelor's degree (or higher) in a Science-related discipline preferred.

 


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Orion Group was founded in 1987 and is now one of the largest, independent, international recruitment companies. We have a network of 200 employees working from 24 offices, delivering a range of services – Talent Acquisition, Recruitment Outsourcing Services, Retained Search, Global Workforce Solutions, Completions & Commissioning and Materials Management – across 68 countries. As a global leader in workforce solutions, we recruit personnel across the Engineering & Technical, Office & Commercial, Scientific and Skilled Trades disciplines, for sectors including Oil & Gas, Life Science, Power & Utilities, Constructions & Infrastructure, Manufacturing and Renewables.