Industry Pharma/Biotech/Clinical Research
City Waterford
Country Ireland
Job Description
Why SimoTech
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.
QA Specialist ****
SimoTech has an opportunity for anexperienced QA Specialist to support the compliant retirement of computerisedsystems associated with the closure of a life sciences manufacturing facilityin Co.
Waterford.
This role is critical to ensuring all decommissioningactivities meet corporate, regulatory, and industry standards.
The QA Specialist – Computer SystemsDecommissioning will play a critical role in ensuring the compliant retirementof computerised systems associated with the closure of a life sciencemanufacturing facility.
This role is responsible for ensuring all activitiesrelated to system decommissioning, data migration, and validation are executedin line with corporate policies, industry standards (e.g., GxP, GAMP 5), andapplicable legal and regulatory requirements.
This role is for a period of 12 months.
Key Responsibilities
ProvideQA oversight for planning and execution of computer system decommissioningactivities.
Ensureadherence to corporate procedures, regulatory guidance, and industry bestpractices.
Reviewand approve validation plans, decommissioning plans, protocols, riskassessments, and final reports.
Maintaintraceability and evidence of compliance throughout system lifecycle closure.
Collaboratewith system owners and SMEs to define validation and decommissioningrequirements.
Supportcreation and execution of documentation (URS, risk assessments, test plans,acceptance criteria).
Ensurevalidated status is maintained until formal decommissioning.
Verifydocumentation accuracy and compliance with GxP, GAMP 5, and ALCOA+ principles.
Ensurecompliant data migration strategies, including extraction, archival,verification, and integrity checks.
Confirmdata retention requirements (corporate, legal, regulatory) are met.
Overseeexecution of migration protocols and approve test results and reports.
Ensurebusiness-critical data remains accessible per statutory timelines.
Workclosely with Manufacturing, QC, Process Development, Engineering, and IT teams.
Alignon timelines, resource requirements, and risk mitigation strategies.
Communicatequality requirements clearly to all stakeholders.
Supportdevelopment of site computer systems decommissioning strategy and schedule.
Contributeto project tracking, reporting, and escalation of compliance risks.
Drivetimely closure of quality records, deviations, CAPAs, and change controls.
Requirements
Qualifications &Experience
Bachelor'sdegree in Life Sciences, Engineering, Computer Science, or related field.
5+years' QA experience in GxP-regulated life sciences.
Experiencewith system validation, data migration, and system decommissioning stronglypreferred.
Familiaritywith MES, laboratory systems, and automation/control systems.
Solidunderstanding of GAMP 5, 21 CFR Part 11, EU Annex 11, and data integrityprinciples.
Strongtechnical writing, communication, and stakeholder management skills.
Abilityto work independently and collaboratively in a fast-paced environment.
What SimoTech CanOffer
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
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