QA Validation Specialist Role Overview
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This position is an exciting opportunity to join a leading multinational organization based in Meath. The QA Validation Specialist will be responsible for maintaining cGMPs for assigned areas in conformance with policies and procedures in compliance with cGMPs, Health Agency regulations, and all other applicable governing regulations.
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The successful candidate will have the necessary experience within an FDA/EMEA regulated environment and fulfill the educational requirements for this role. They will be part of cross-functional teams and participate in investigations and risk assessments related to deviations/complaints and changes, ensuring appropriate actions are implemented timely.
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The role involves participating in project teams through all phases of projects - conceptual and detailed design, equipment procurement, construction, installation, start-up, commissioning, and qualification, and system release. The QA Validation Specialist will provide QA review and approval of Change Controls, Deviations/CAPAs, SOPs, and related documentation for compliance to GMP and site requirements at the facility.
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Key Responsibilities:
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1. Lead daily on cross-functional teams to address compliance issues and achieve project milestones.
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2. Participate in investigations and risk assessments related to deviations/complaints and changes, ensuring appropriate actions are implemented timely.
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3. Provide QA review and approval of Change Controls, Deviations/CAPAs, SOPs, and related documentation for compliance to GMP and site requirements at the facility.
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4. Participate in project teams through all phases of projects - conceptual and detailed design, equipment procurement, construction, installation, start-up, commissioning, and qualification, and system release.
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5. Quality oversight of computer system validation activities for lifecycle approach in accordance with good automation practices, DQ, IQ, OQ, PQ, and PV following validation plans and complying with cGMP and company procedures.
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6. Evaluate new and prospective regulatory guidance and industry best practice and determine impact on Quality systems, identifying and implementing appropriate updates where required.
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7. Assist in the creation and maintenance of QA policies, SOPs, and reports in line with site requirements.
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8. Support an environment of continuous improvement by identifying and implementing efficiencies and quality improvements.
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9. Participate in and support risk management activities in line with relevant guidance and best industry practice.
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10. Assist in the execution of the internal audit programme including the performance of audits as required.
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11. Work collaboratively to foster strong relationships with management and colleagues and to drive a safe and compliant culture.
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12. Escalate compliance risks to management in a timely manner.
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13. Will be flexible to take on additional tasks and responsibilities at the discretion of the Associate Director of QA Validation.
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14. Educational Requirements:
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* Degree qualification (Science/Quality/Technical).
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15. Experience Requirements:
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* 5+ years' experience, ideally in Quality Assurance / Validation within the Biological and/or pharmaceutical industry as part of a computer systems validation, validation, engineering or IT/OT function.
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* Experienced in the execution of commissioning and qualification/validation of computerized systems and process equipment.
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* Experience in quality management systems such as Veeva Vault, SAP, Trackwise, KNEAT, etc.
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