QA Specialist

Dublin

9 months ago

Applications closed

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Senior Regulatory Affairs and QA Specialist - Medical Devices

Senior Regulatory Affairs and QA Specialist: Medical Devices

Senior Regulatory Affairs & QA Specialist - Medical Devices

Senior Medical Devices Regulatory & QA Lead

Senior Medical Devices Regulatory & QA Leader

Senior Regulatory Affairs & QA Lead - Medical Devices

Quality Assurance Specialist
Actively recruiting for a QA Specialist to become a key member of the Quality Team within a Dublin based Biotech multinational.

Duties/Responsibilities:
• Compilation and review of batch release dossiers for Qualified Person certification of IMP to clinical trials.
• Updates and maintains the site Manufacturing and Importation Authorisation (MIA) in accordance with regulatory requirements and maintains the Site Master File.
• Generates and maintains Product Specification Files (PSF) for IMP.
• Provides QA support and oversight of packaging and labelling 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 (EMEA and Asia)
• Supports 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. Tracks 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.

Skills/Qualifications:
• 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.

For more information and a full job spec contact Nicola on (phone number removed) or email your CV in the strictest confidence to (email address removed)

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