Quality Assurance Specialist

Role Overview

We are seeking a Quality Assurance Specialist to oversee and support quality processes within Analytical, Warehouse, and Facilities Management operations in a pharmaceutical manufacturing environment. This role includes managing deviations, leading root cause analysis, CAPAs, and change controls to ensure compliance and operational excellence.

Key Responsibilities

• Oversee quality assurance activities supporting Analytical, Warehouse, and Facilities Management functions including managing deviations, root cause analysis, corrective and preventive actions (CAPAs), and change control procedures.
• Act as the quality functional expert in the cross-functional team managing the introduction of new products and materials at the Carlow site.
• Review and assess documentation related to new product and material introductions, encompassing Material Packs, QC Test Specifications, Bills of Materials (BOMs), and Supplier Qualification and Oversight documentation.
• Develop and track supplier performance indicators, participate in material review boards and conduct quarterly assessments of key suppliers, actively engaging in relevant cross-functional forums.
• Maintain and manage the approved supplier list within the Supplier Management system, ensuring accurate setup of suppliers and materials utilized at the site.
• Support resolution of deviations and atypical situations, initiating and following up on corrective and preventive actions as necessary.
• Provide expert quality oversight for new product and material introductions while coordinating activities with external parties.
• Author, review, and approve required protocols and reports associated with technology transfers, method qualifications, and validations.
• Conduct quality reviews and provide approvals related to engineering, validation, automation, and utilities commissioning and qualification processes.
• Serve as the quality point of contact both within the site and for external stakeholders, coordinating and participating in Quality working group meetings.
• Drive compliance adherence by implementing divisional policies, guidelines, and regulatory standards. Proactively assess site compliance in light of emerging trends and spearhead initiatives to enhance compliance status and operational efficiency.
• Actively engage in Plant and Quality committees and collaborate with other functional teams at the site to ensure quality goals are met.

Candidate Requirements

• Between 3 to 5 years of professional experience in quality roles, preferably within pharmaceutical manufacturing settings.
• Thorough understanding of regulatory and code requirements applicable in Ireland, Europe, and internationally.
• Familiarity with current Good Manufacturing Practices (cGMP) and Good Distribution Practices (GDP) is advantageous.
• Strong technical skills in report, standards, and policy documentation.
• Experience in equipment and process validation activities.
• Knowledge of sterile filling processes and associated equipment.
• Proficiency with Microsoft Office suite and relevant computer applications.
• Exposure or knowledge of Lean Six Sigma principles is preferred.
• Excellent collaboration abilities and capacity to operate effectively in team environments to set and achieve priorities.
• Capability to independently manage projects and improvement initiatives with minimal supervision.
• Proven track record of driving task completion efficiently.
• Sound decision-making skills coupled with a strong sense of responsibility and accountability.
• Demonstrated problem-solving aptitude.
• A Bachelor’s degree or higher qualification in a related scientific discipline is desired.