QAV Specialist 1680

Whatis it like to work at SimoTech? With a strong collaborative teamworkculture based on respect, trust, and excellence, we play a criticalpartnering role to our clients' life-changing supply of products topatients. In return, there is excellent salary, benefits, careerprogression, educational support andmuch more.

SimoTechhas an opportunity for an experienced QAV Specialist to support the compliant retirement of computerised systems associated with the closure of a life sciences manufacturing facility inCo. Waterford . This role is critical to ensuring all decommissioning activities meet corporate, regulatory, and industry standards.

The QAV Specialist - Computer Systems Decommissioning will play a critical role in ensuring the compliant retirement of computerised systems associated with the closure of a life science manufacturing facility. This roleis responsible forensuring all activities related to system decommissioning, data migration, and validation are executed in line with corporate policies, industry standards (e.g., GxP , GAMP 5), and applicable legal and regulatory requirements.

• Provide QA oversight for planning and execution of computer system decommissioning activities.
  
• Ensure adherence to corporate procedures, regulatory guidance, and industry best practices.
  
• Review and approve validation plans, decommissioning plans, protocols, risk assessments, and final reports.
  
• Maintain traceability andevidenceof compliance throughout system lifecycle closure.
  
• Collaborate with system owners and SMEs to define validation and decommissioning requirements.
  
• Support creation and execution of documentation (URS, risk assessments, test plans, acceptance criteria).
  
• Ensure validated status ismaintaineduntil formal decommissioning.
  
• Verify documentation accuracy and compliance with GxP , GAMP 5, and ALCOA+ principles.
  
• Ensure compliant data migration strategies, including extraction, archival, verification, and integrity checks.
  
• Confirm data retention requirements (corporate, legal, regulatory) are met.
  
• Oversee execution of migration protocols and approve test results and reports.
  
• Ensure business-critical dataremainsaccessible per statutory timelines.
  
• Work closely with Manufacturing, QC, Process Development, Engineering, and IT teams.
  
• Align on timelines, resource requirements, and risk mitigation strategies.
  
• Communicate quality requirements clearly to all stakeholders.
  
• Support development of site computer systems decommissioning strategy and schedule.
  
• Contribute to project tracking, reporting, and escalation of compliance risks.
  
• Drivetimelyclosure of quality records, deviations, CAPAs, and change controls.
  

• Bachelor's degree in Life Sciences, Engineering, Computer Science, or related field.
  
• 5+ years' QA experience in GxP -regulated life sciences.
  
• Experience with system validation, data migration, and system decommissioning strongly preferred.
  
• Familiarity with MES, laboratory systems, and automation/control systems.
  
• Solid understanding of GAMP 5, 21 CFR Part 11, EU Annex 11, and data integrity principles.
  
• Strong technical writing, communication, and stakeholder management skills.
  
• Ability to work independently and collaboratively in a fast-paced environment.
  

• Role provides ahigh degree of autonomy to allow the successfulcandidate to reach their fullpotential.
  
• Develop newskills and enhance technical ability by working withinnovative technologies in a multi- disciplinedenvironment.
  
• Opportunity towork with large corporate clients