In AbbVie Ballytivnan, we are recruiting for a Training and Documentation Specialist to join our team. This position will report into the Quality Systems Manager . The QA Compliance Specialist is responsible for documenting and establishing a quality system which ensures full compliance with all regulatory and AbbVie requirements. The QA Compliance Specialist will have responsibility to assess and report on the effectiveness of the quality system to senior management. What you will do: Coordinating the quality system, ensuring full compliance by all personnel with its requirements. Coordination of Product Quality Reviews activities. Management of all Technical Agreements from initiation, review, approval and storage. Coordination and Management of all Track and Trend activities to support Manufacturing and QC. Driving a QRM approach to all activities on site. Coordination and facilitation of all Site RCS and FMEA activities. Auditing the quality system per the documented internal audit schedule. Assisting in the documentation, investigation of and coordinating customer complaints/exceptions by ensuring implementation of effective corrective / preventive action where necessary. Ensuring that products manufactured at Abbvie Biologics Ballytivnan meet requirements of end users, of regulatory authorities and of the company. Measuring performance of the quality system and reporting on this at the management review meeting and during quality performance meetings. Coordinating change management, change control and Change planning activities. Monitoring quality performance and advising management personnel on major quality issues. Liaison with AbbVie Global Quality Assurance, FDA, HPRA and other regulatory bodies. Regulatory review. Initiation and Completion of Quality related investigations and verification of the effectiveness of CAPA’s as required. Establishing Corrective / Preventive Action system and procedures. Management of the Supplier program including the ASL, Performance metrics and Audit Schedules. Creation and approval of commodity specifications as required. Performance of Vendor audits as required Supporting all aspects of inspection readiness including preparation activities, logistic activities, and generation of follow up responses and management of proof books.
What you will need: A third level qualification in a science, quality or engineering discipline Minimum 3 years’ Experience in a similar role in a Pharmaceutical or Sterile Manufacturing environment A strong knowledge of regulatory requirements is required. Excellent written and verbal communication skills with a strong attention to detail.
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