QAV Specialist 1680

Company : Simotech

Job Type : Full Time

Dublin, Ireland

Number of Applicants

:

000+

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Job Description - QAV Specialist 1680

Why SimoTech

What
is it like to work at SimoTech? With a strong collaborative teamwork
culture based on respect, trust, and excellence, we play a critical
partnering role to our clients’ life -changing supply of products to
patients. In return, there is excellent salary, benefits, career
progression, educational support and much more.

QAV Specialist 1680

SimoTech has 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 in Co. 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 role is responsible for ensuring 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.

Key Responsibilities

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 and evidence of 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 is maintained until 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 data remains accessible 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.
Drive timely closure of quality records, deviations, CAPAs, and change controls.

Requirements

Qualifications &
Experience

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.

Benefits

What SimoTech Can
Offer

Role provides a
high degree of autonomy to allow the successful
candidate to reach their full
potential.
Develop new
skills and enhance technical ability by working with
innovative technologies in a multi - disciplined
environment.
Opportunity to
work with large corporate clients

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