Exalto consulting are recruiting for a contract Lab validation analyst to work within laboratory systems in regulated (GxP) environments. This role is critical in ensuring lab systems meet regulatory requirements and perform reliably throughout their lifecycle.
Key Responsibilities:
- Lead and execute computer system validation (CSV) activities for lab instruments, software, and analytical platforms (e.g., CDS, LIMS, ELN, SDMS).
- Author, review, and approve validation deliverables (e.g., URS, FRS, RTM, IQ/OQ/PQ protocols, validation plans, and reports).
- Ensure compliance with GAMP 5, 21 CFR Part 11, EU Annex 11, and relevant data integrity standards.
- Support risk assessments and impact analyses for system changes and new implementations.
- Partner with QA and Lab/IT stakeholders to define validation strategy, timelines, and resource needs.
- Maintain the validated state of systems through periodic reviews, audit support, and change control.
- Provide guidance and training to system owners and users on validation processes and regulatory requirements.
- Participate in vendor audits and qualification efforts where required.
- Bachelor's degree in Life Sciences, Engineering, Computer Science, or related field.
- 3+ years of experience in a GxP-regulated lab environment performing system validation or CSV.
- Familiarity with lab informatics systems such as Waters Empower, Agilent OpenLab, LabVantage, MasterControl, etc.
- Solid knowledge of regulatory requirements including GAMP 5, 21 CFR Part 11, Annex 11, and ALCOA+ data integrity principles.
- Experience with documentation and testing tools such as HP ALM, ValGenesis, or similar.
Lab validation analyst (GxP) - Dunboyne (Ireland) on site - contract - £450 per day