EDUCATION AND EXPERIENCE:

• Postgraduate qualification in an engineering or science discipline would be advantageous (Science/Quality/Technical).
• Min 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.
• Experienced in the execution of commissioning and qualification/validation of computerized systems and process equipment (e.g. bioreactors and process vessels, chromatography, ultrafiltration, autoclaves, parts washers).
• Knowledge of GAMP requirements to the qualification and validation of computerised systems a distinct advantage.
• Experience supporting complex investigations and problem-solving techniques.
• Project Manager capability with significant understanding of Power BI.
• Demonstrated experience in QRM, Investigations, Problem solving as a Quality SME.
• Strong written and verbal communication skills.
• Ability to think logically and be proactive under pressure.
• Ability to work as part of a team and on own initiative in a constructive manner.
• Strong attention to detail and precision in preparing and reviewing GMP documentation.
• Experience in quality management systems such as Veeva Vault, SAP, Trackwise, KNEAT, etc.
• Demonstrated knowledge and application of industrial regulations including those of FDA, HPRA, EMEA and other authorities related to Biologics and/or Pharmaceuticals.
• Experience in direct interactions with regulatory agencies during site inspections.

THE ROLE:

PE Global is currently recruiting for a Senior QA Validation Specialist on behalf of a leading pharma company based in Meath. This is an initial contract role until the end of 2025.

JOB PURPOSE:

The QAV / DDQ Specialist role will have quality oversight of Digital Data Quality and Validation activities. The role is a key member of the quality Assurance team ensuring the site has a strong operational compliance focus aligned with the principles and expectations of cGMP regulations. The role 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. The Quality Assurance Validation Specialist will fulfill the educational requirements for this role and have the necessary experience within an FDA/EMEA regulated environment.

RESPONSIBILITIES:

• Lead, facilitate and/or participate daily on cross-functional teams to collaboratively actively to address compliance issues and achieve project milestones.
• Participate in investigations and risk assessments related to deviations/ complaints and changes, ensuring appropriate actions are implemented timely.
• 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.
• Provide QA review and approval of Change Controls, Deviations/CAPAs, SOPS and related documentation for compliance to GMP and site requirements at the facility.
• Provide QA oversight to the qualification/validation, technical transfers, regulatory approvals and commercial/clinical operations at the facility.
• Review and Approval of validation lifecycle documents and reports.
• Quality oversight of computer system validation activities for life cycle approach in accordance with good automation practices, DQ, IQ, OQ, PQ and PV following validation plans and complying with cGMP and company procedures.
• Evaluate new and prospective regulatory guidance and industry best practice and determine impact on Quality systems, identifying and implementing appropriate updates where required.
• Assist in the creation and maintenance of QA policies, SOP’s and reports in line with site requirements.
• Support an environment of continuous improvement by identifying and implementing efficiencies and quality improvements.
• Participate in and support risk management activities in line with relevant guidance and best industry practice.
• Assist in the execution of the internal audit programme including the performance of audits are required.
• Work collaboratively to foster strong relationships with management and colleagues and to drive a safe and compliant culture.
• Ensures the escalation of compliance risks to management in a timely manner.