Quality Assurance Specialist

Key Responsibilities

• Provide quality oversight for the introduction of new products and materials, including coordination with external partners and suppliers.
• Support QA activities across Analytical, Warehouse, and Facilities functions, including deviations, root cause analysis, CAPAs, and change controls.
• Act as a QA representative on cross-functional teams for new product and material introduction.
• Review and approve key documentation such as material packs, QC test specifications, BOMs, and supplier qualification records.
• Develop and monitor supplier performance metrics; participate in material review boards and supplier review meetings.
• Maintain the Approved Supplier List within the supplier management system, ensuring accurate setup and compliance.
• Lead or support deviation investigations, atypical events, and CAPA implementation and closure.
• Author, review, and approve protocols and reports for technology transfer, method qualification, and validation.
• Provide QA oversight for engineering, validation, automation, and utilities commissioning/qualification activities.
• Act as a key quality point of contact at site level and with external stakeholders.
• Drive compliance with regulatory and internal standards; identify gaps and lead continuous improvement initiatives.
• Participate in site quality and plant committees, collaborating with cross-functional teams.

Experience, Knowledge & Skills

• 3-5 years' experience in a QA role within pharmaceutical manufacturing (or similar regulated industry).
• Strong knowledge of regulatory requirements (EU, Irish, and international standards).
• Familiarity with cGMP and GDP guidelines.
• Experience in deviation management, CAPA, and change control systems.
• Background in equipment/process validation and (ideally) sterile manufacturing.
• Strong technical writing and documentation skills.
• Proficiency in Microsoft Office and quality systems.
• Knowledge of Lean Six Sigma principles (desirable).
• Strong teamwork, communication, and stakeholder management skills.
• Ability to work independently, take ownership, and drive tasks to completion.
• Solid problem-solving and decision-making capability.

Qualifications

• Bachelor's degree (or higher) in a science-related field (e.g., Chemistry, Biology, Pharmaceutical Sciences).