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We are recruiting a QA Specialist to work for a Biotechnology Company focused on the development of Antibody based Drug Conjugates (ADCs) targeting difficult-to-treat cancers.
This is a hybrid role, based in Dublin, an opportunity for working remotely with visits to the Company’s UK and US facilities and vendor sites as appropriate.
The successful candidate will be responsible for assist the quality management system and support in oversight of organizations contracted by the company for products manufactured for use in clinical trials in the US, Europe, Canada, Australia.
• Support the development and implementation of quality systems including but not limited to:
Deviations; CAPA; Audits; Customer Complaints; Change Control; Supplier Qualification.
• Development, management, and maintenance of appropriate procedures to ensure regulatory compliance.
• Monitoring and communication with CMOs to ensure timely receipt of batch documentation.
• Review and approve GMP documents received from CMOs.
• Compilation and reporting of deviations, metrics, change controls, customer complaints and any other metrics to support client and company Management Review meetings.
• Monitor QA/QP activities of contractors and suppliers.
• Compilation and review of CMO batch documentation, including but not limited to: Batch records, Change Control documents, failure investigations and temperature monitoring records.
• Support supplier qualification activities ensuring approved supplier and customer lists are maintained.
• Develop and conduct training for quality department, as necessary.
• Participate in regulatory inspections and customer audits as necessary.
• Point out gaps in quality systems and develop practical plans for correction.
• Experience on a site as QA with large and small molecule manufacture and packaging.
• 3rd Level Qualification in a science related discipline.
• 7+ years’ experience in GMP, encompassing Quality Management or Compliance role preferably with a virtual organization.
• Knowledge of Good Manufacturing Practices (GMPs) and Good Documentation Practices (GDPs)
• Understanding of electronic document management systems.
• Knowledge of GXP Regulations (ISO, ICH, EU GMPs, FDA, etc.)
• Familiarity with virtual CDMOs and review of their documentation.
• High level Computer Literacy and competency –Microsoft Project, Microsoft Office, Excel.
• QP eligible preferrable.