Quality Systems Specialist

PE Global is currently recruiting for a Quality Systems Specialist on behalf of our client based in Dublin.

This is an initial 12 month initial contract role.

Job Summary: We are seeking an experienced quality professional with an information delivery background to join our team. This role requires a strong understanding of Pharmaceutical Quality Systems, data validation and data verification to support key business deliverables.

Job Duties & Responsibilities

• Support the delivery of a Quality Management Review (QMR) project
• Support Information delivery across all business units using Power BI or other Data reporting and visualizations tools as required.
• Support data validation and data verification activities, proactively identify data integrity issues and support corrective actions.
• Gather information from necessary business partners to create and monitor of Quality Systems metrics in compliance with internal and external requirements.
• Assist in the development of appropriate systems and processes to ensure delivery of information across function to support enhanced performance culture.
• Collaborate with stakeholders to identify and support value-added improvements and Key Performance Indicators (KPIs) to the QMR.
• Support procedural documentation and working practice document creation, update, and execution.
• Ensure compliance with GxP (Good Practice) guidelines and regulatory requirements in all documentation and quality systems activities.
• Maintain thorough and accurate GxP documentation to support compliance and inspection readiness.
• Triage report requests/issues related to QMR via our ticketing system.
• Provide forward thinking innovative solutions and identify opportunities to add value to the teams’ deliverables.
• Other duties as required to support the growing Quality organization.

Essential Qualifications

• 5+ years of experience in a Quality Systems role within the pharmaceutical industry and working to GxPs.
• Knowledge of requirements for a Quality Management System
• Experience in authoring, reviewing, and maintaining GxP documentation to ensure regulatory compliance
• Direct experience and comprehension of systems supporting pharmaceutical manufacturing, IT infrastructure, and/or laboratory operations.
• Prior experience in project leadership within a matrix environment.
• Business engagement skills, with the ability to partner with both technical and non-technical roles
• Able to prioritize and manage workload and manage shifting priorities based on criticality to ensure commitments are met.
• Ability to work to tight deadlines
• Strong understanding of GxP guidelines and compliance requirements.
• Experience working in data warehouse building and administration

Preferred Qualifications

• Analytical problem-solving skills applied to issue identification and resolution.
• Integrating diverse perspectives to add value to the achievement of team goals and timely decision-making.
• Project management skills combined with a sense of urgency and a proven history of producing quality deliverables.
• Experience with quality management system software such as, Veeva,
• Experience in system validation

Education

• Bachelor’s degree (or equivalent) in a technical or life sciences discipline relevant experience and education.

Interested candidates should submit an updated CV.

Please click the link below to apply, call Audrey on 0214297900 or alternatively send an up to date CV to audrey.mccarthy@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***