The QA Specialist is a senior & active role within the broader QA function of a Dublin based biopharma multinational. The QA Specialist will typically report to a QA Senior Manager & will be required to be a Subject Matter Expert in their assigned area of responsibility.
• Provide Quality direction and input at Change Control and Deviation Review Boards and assume oversight of change control and Deviation/CAPA records; ensuring scope of record is clear and implementation activities are robust and timely.
• Write, review and approve SOPs in accordance with site Policies.
• Participate in site activities associated with QMS programs (e.g., Validation, Complaints, Change Control) and provide active input into shaping the future direction of these systems.
• Review and approval of Deviations and associated CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable
• Responsibility and oversight for the development and maintenance of site quality processes, quality compliance and auditing related procedures and processes, including but not limited to, Documentation Management , Change Control, Deviation/CAPA processes, Quality Risk Management, Internal auditing/self-inspection program, QMS and the overall Site Management review process.
• Ensures that the self-inspection, audit and key compliance systems are effectively implemented, revised and optimised to ensure a continuous drive to improve product and process quality at the site.
• University degree in Engineering or Science related discipline preferred.
• 8yrs + within the pharmaceutical or biotechnology industry
• Excellent written and verbal communication skills
• Experience working with dynamic cross-functional teams and proven abilities in decision making
• Strong organizational skills, including ability to follow assignments through to completion
• Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Deviation investigations
• Experience with Regulatory inspections.
• Experience working in aseptic operations, protein formulation, vial and syringe filling.