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.
