QA Validation Specialist: LIMS & Lab Systems

R&D Partners

Ireland

On-site

EUR 50,000 - 70,000

Full time

12 hours ago
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Job summary

R&D Partners in Ireland seeks a QA Validation Specialist on a contract basis to validate LIMS, laboratory equipment, and computerized systems in a regulated pharmaceutical environment. This role supports data integrity and readiness for commercial operations as two products near launch.

This on-site position is based in Cashel and requires the right to work in Ireland. You will collaborate with Quality Control and IT to ensure compliant system setup and thorough documentation.

Qualifications

  • Background in science, engineering, or a related technical field.
  • Hands-on experience validating LIMS, lab equipment, and computerized systems.
  • Familiarity with regulatory standards like GAMP 5, Annex 11, and 21 CFR Part 11.
  • Strong communication and documentation skills.
  • Ability to collaborate across teams.

Responsibilities

  • Review and approve validation documents for lab systems and equipment.
  • Oversee testing and qualification activities for computerized systems and lab instruments.
  • Help create and maintain validation plans and related documentation.
  • Ensure all validation activities meet regulatory standards and guidelines.
  • Work with Quality Control and IT teams to ensure proper system setup and data security.
  • Address and resolve issues related to lab system validation.
  • Review and approve procedures, protocols, and technical documents.
  • Participate in risk assessments and ensure data integrity for lab systems.
  • Support audits and inspections as a SME for validation processes.

Skills

LIMS validation
Lab equipment validation
Computerized systems validation
Regulatory awareness
Cross-functional collaboration

Education

Science/Engineering degree

Tools

GAMP 5
Annex 11
21 CFR Part 11

Job description

R&D Partners in Ireland seeks a QA Validation Specialist on a contract basis to validate LIMS, laboratory equipment, and computerized systems in a regulated pharmaceutical environment. This role supports data integrity and readiness for commercial operations as two products near launch.

This on-site position is based in Cashel and requires the right to work in Ireland. You will collaborate with Quality Control and IT to ensure compliant system setup and thorough documentation.

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