Test Triangle Ltd
QA Validation Specialist – Lab 6 mth contract
Test Triangle Ltd, Ireland, New Hampshire, United States
Overview
Full time | Test Triangle | Ireland Posted On 29/10/2025 Work Experience 5+ years Medical City Cashel State/Province Tipperary E25 Responsibilities
Summary
:
QA Validation role to ensure Qualification of LIMS and Laboratory instruments is performed in compliance with regulatory requirements, company policy and procedures. Support the introduction, implementation, and lifecycle management of LIMS, Empower and other Lab software within QC and analytical laboratories. Serve as QA Validation SME, overseeing Computer System Validation (CSV) activities, including URS, FS, RA, IQ, OQ, PQ, and validation reports. Ensure compliance with EU GMP, FDA, EMA, and Annex 11 standards for electronic systems. Collaborate with Quality, QC, Manufacturing, IT, and Regulatory teams to optimize lab workflows supporting product testing. Support integration of analytical instruments and other quality systems with LIMS. Provide user training, troubleshooting, and continuous improvement support for lab personnel. Drive change control, deviation management, and periodic review processes related to LIMS and associated systems. Maintain audit readiness, ensuring documentation and processes align with corporate and regulatory requirements. Qualifications
Bachelor’s or Master’s degree in Pharmaceutical Sciences, Chemistry, Biotechnology, Life Sciences, or IT/Computer Science. 5+ years’ experience in the pharmaceutical/medical device industry with a focus on QC laboratory software, LIMS implementation, and validation or Empower upgrades. Strong expertise in CSV methodology, validation protocols, and regulatory frameworks. Comprehensive knowledge of cGMP, pharmacopeial standards (USP, EP, JP), and global regulatory guidelines (FDA, EMA). Skilled in equipment and analytical instrument qualification, calibration, and validation maintenance. Excellent documentation skills, including accurate preparation and maintenance of SOPs, validation protocols, and technical reports. Proven project management abilities, ensuring adherence to timelines, budgets, and quality standards. Deep understanding of data integrity principles, validation documentation, and regulatory compliance. Effective problem-solver in validation challenges, providing practical and risk-based solutions.
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Full time | Test Triangle | Ireland Posted On 29/10/2025 Work Experience 5+ years Medical City Cashel State/Province Tipperary E25 Responsibilities
Summary
:
QA Validation role to ensure Qualification of LIMS and Laboratory instruments is performed in compliance with regulatory requirements, company policy and procedures. Support the introduction, implementation, and lifecycle management of LIMS, Empower and other Lab software within QC and analytical laboratories. Serve as QA Validation SME, overseeing Computer System Validation (CSV) activities, including URS, FS, RA, IQ, OQ, PQ, and validation reports. Ensure compliance with EU GMP, FDA, EMA, and Annex 11 standards for electronic systems. Collaborate with Quality, QC, Manufacturing, IT, and Regulatory teams to optimize lab workflows supporting product testing. Support integration of analytical instruments and other quality systems with LIMS. Provide user training, troubleshooting, and continuous improvement support for lab personnel. Drive change control, deviation management, and periodic review processes related to LIMS and associated systems. Maintain audit readiness, ensuring documentation and processes align with corporate and regulatory requirements. Qualifications
Bachelor’s or Master’s degree in Pharmaceutical Sciences, Chemistry, Biotechnology, Life Sciences, or IT/Computer Science. 5+ years’ experience in the pharmaceutical/medical device industry with a focus on QC laboratory software, LIMS implementation, and validation or Empower upgrades. Strong expertise in CSV methodology, validation protocols, and regulatory frameworks. Comprehensive knowledge of cGMP, pharmacopeial standards (USP, EP, JP), and global regulatory guidelines (FDA, EMA). Skilled in equipment and analytical instrument qualification, calibration, and validation maintenance. Excellent documentation skills, including accurate preparation and maintenance of SOPs, validation protocols, and technical reports. Proven project management abilities, ensuring adherence to timelines, budgets, and quality standards. Deep understanding of data integrity principles, validation documentation, and regulatory compliance. Effective problem-solver in validation challenges, providing practical and risk-based solutions.
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