Summary:
Our pharmaceutical client based in County Kerry is seeking a QC Instrument Validation Specialist with strong experience in the qualification and calibration of analytical laboratory instruments. This role is key to their expansion and will be working client side to ensure the lab instruments are validated and ready for operations.
Responsibilities:
* Work with the approved vendors to ensure the installation, calibration and validation of lab instrumentation to the site.
* Plan and execute instrument qualification activities (IQ/OQ/PQ) for QC laboratory equipment such as HPLCs, GCs, UV-Vis spectrophotometers, balances, pH meters, and other analytical instruments.
* Perform and/or coordinate instrument calibration and ensure traceability to certified standards.
* Prepare and review validation protocols, reports, and risk assessments in line with site and regulatory requirements.
* Collaborate closely with QC, QA, IT, and Engineering to ensure timely and compliant execution of validation projects.
* Ensure data integrity principles are applied throughout all validation and qualification processes.
* Troubleshoot equipment qualification issues and implement appropriate corrective and preventive actions.
* Maintain accurate and up-to-date validation documentation in compliance with cGMP and site SOPs.
* Support internal and external audits and inspections by providing complete and current validation records.
* Contribute to continuous improvement initiatives in QC systems and validation practices.
Qualifications & Experience:
* Degree in Engineering, Analytical Chemistry, Life Sciences, or a related discipline.
* Minimum 2-3 years of experience in a GMP-regulated pharmaceutical or biotechnology environment.
* Proven experience with analytical instrument validation in a QC or regulated laboratory setting.
* Working knowledge of GMP, data integrity (ALCOA+), validation lifecycle, and regulatory guidelines (e.g., FDA, EMA, GAMP 5).
* Excellent documentation and technical writing skills with attention to detail.
* Familiarity with computerized system validation (CSV) and software tools such as Empower, LabWare, or LIMS is an advantage.
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