QA CSV Specialist

We are looking for a QA CSV Specialist to join a Pharmaceutical Company in Tipperary. The focus will be to ensure Qualification of LIMS and Laboratory instruments is performed in compliance with regulatory requirements, company policy and procedures.

This is a 12 month hourly rate contract position.

Requirements:

• 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.
• Collaborate with Quality, QC, Manufacturing, IT, and Regulatory teams to optimize lab workflows supporting product testing.
• Ensure compliance with EU GMP, FDA, EMA, and Annex 11 standards for electronic systems.
• 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.

Skills, Attributes, Experience:

• 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.
• Skilled in equipment and analytical instrument qualification, calibration, and validation maintenance.
• 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).
• Strong documentation skills, including accurate preparation and maintenance of SOPs, validation protocols, and technical reports.
• Project management experience is a benefit, 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.