Help launch breakthrough therapies by ensuring lab systems and data integrity are audit-ready in this hands‑on QA Validation role in Cashel.
R&D Partners is seeking a QA Validation Specialist on a contract basis to support validation activities related to Laboratory Information Management Systems (LIMS), analytical lab equipment, and computerised systems within a GMP-regulated pharmaceutical environment. This role is critical in ensuring data integrity, system compliance, and readiness for commercial operations as the company prepares to launch two products by year‑end.
The successful candidate will work cross‑functionally with IT, Quality Control, and Engineering teams to ensure robust validation of lab systems and equipment in alignment with regulatory expectations.
Please note that this is an on‑site position in Cashel and to be considered for this role you must have the right to work in this location.
Key Responsibilities:
* Review and approve validation documentation (IQ/OQ/PQ) for LIMS, lab instruments, and computerised systems.
* Provide QA oversight during execution of CSV and equipment qualification activities.
* Support the development and maintenance of the Computer System Validation Master Plan and related documentation.
* Ensure validation activities comply with GAMP 5, Annex 11, and 21 CFR Part 11 requirements.
* Collaborate with QC and IT teams to ensure proper system configuration, data integrity controls, and audit trail functionality.
* Lead or support investigations and CAPAs related to lab system validation deviations or issues.
* Review and approve SOPs, protocols, reports, and technical documentation for lab systems and equipment.
* Participate in risk assessments and data integrity reviews for lab systems.
* Support internal and external audits, acting as SME for CSV and lab equipment validation.
Qualifications & Experience:
* Degree in scientific or technical discipline (e.g., Computer Science, Life Sciences, Engineering).
* Minimum 5 years of experience in a GMP-regulated pharmaceutical or biopharmaceutical environment.
* Proven experience in CSV, LIMS validation, and lab equipment qualification.
* Strong understanding of GAMP 5, Annex 11, and 21 CFR Part 11 compliance.
* Excellent documentation, communication, and cross‑functional collaboration skills.
* Experience supporting audits and inspections as a validation SME.
For more information, please contact Billy O'Brien.
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists visit the 'Contact Us' page.
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