Company Profile:
Our client a leading multinational biopharma organization is hiring for a QA Specialist on an initial 12 month contract for their best in class facility in Dublin.`
Excellent opportunity to gain further exposure to a range of QA processes and enhance one's professional development.
Core Responsibilities:
• Compile and review of batch release dossiers for the Qualified Person certification of IMP to clinical trials.
• Update and maintains the site Manufacturing and Importation Authorization (MIA) in accordance with regulatory requirements and maintain the Site Master File.
• Generate and maintains Product Specification Files (PSF) for IMP.
• Provide QA support and oversight of packaging and labeling operations for IMP.
• Support the generation and ongoing maintenance of Quality Agreements.
• Provides Quality Assurance support in the Use Date Extension process.
• Provides Quality Assurance oversight and support (GMP/GDP guidance and training) for CSO Logistics
• Support in a timely manner, investigations of non-conformances and quality incidents as QA. Resolves and documents in the Quality Management System quality. Conducts appropriate follow-up, as required.
Track deviation, investigations and CAPAs.
• Generate and complete QA review of supplier/customer qualification documentation for the Responsible Person (RP). Ensure supplier/customer qualification and re-qualification is complete within required timelines.
• Provide support to Health Authority inspections and internal audits as required.
• Prepare and review procedural documents.
• Complete Change control assessment and CAPA evaluation/CAPA close-out
• Interface with relevant departments to ensure compliance with corporate policies, GMP and regulatory requirements.
• Support OPEX programs and champion continuous quality improvement initiatives.
Key Requirements:
• A degree in science, engineering or related discipline is essential along with 3 years’ experience in a role within the biopharmaceutical/pharmaceutical industry
• Demonstrated strong knowledge of ICH/GMP, data integrity, regulatory guidelines/directives, clinical supply chain processes and principles of Quality Assurance
• Required to work on his/her own initiative in addition to working as part of a team. The candidate must be able to work across a team matrix in order to meet accelerated timelines.
• Excellent communication, presentation and critical thinking skills are essential.
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