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      Urgent! QA Validation Specialist – Lab 6 mth contract - Local Job Opening in Cashel
 
                        
                         QA Validation Specialist  Lab 6 mth contract Summary: QA Validation role to ensure Qualification of LIMS and Laboratory instruments is performed in compliance with regulatory requirements, company policy and procedures.
Key Responsibilities: 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 & Experience: Bachelors or Masters 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.
Education and Qualifications
Bachelor’s or Master’s degree in one of the following disciplines:
Pharmaceutical Sciences ,Chemistry, Biotechnology, Life Sciences Engineering, Information Technology / Computer Science
Minimum 5 years’ experience in the pharmaceutical or medical device industry, specifically within:
QA Validation or Computer System Validation (CSV)
QC Laboratory software and systems (e.g., LIMS, Empower)
Laboratory instrument qualification and validation
5+ years
Strong knowledge of Computer System Validation (CSV) principles and lifecycle management.
Hands-on experience with LIMS and Empower implementation, validation, and maintenance.
Proficiency in qualification activities (IQ, OQ, PQ) for laboratory instruments and systems.
Deep understanding of regulatory standards – EU GMP, FDA, EMA, Annex 11, and GAMP 5.
Comprehensive grasp of cGMP and pharmacopeial standards (USP, EP, JP).
Expertise in data integrity and good documentation practices (GDP).
Ability to prepare, review, and approve validation protocols, reports, and SOPs. Experience with change control, deviation management, and periodic review processes.
Strong analytical and problem-solving abilities with a risk-based approach.
Effective communication and collaboration with cross-functional teams (QA, QC, IT, Manufacturing).
Excellent documentation and technical writing skills.
Project management skills — managing validation deliverables within timelines and quality standards.
Experience in audit readiness and supporting regulatory inspections.
Ability to train, guide, and support laboratory users on validated systems.
Educational background in Science, Engineering, or IT with 5+ years’ pharmaceutical or medical device experience.
                      
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Unlock Your QA Validation Potential: Insight & Career Growth Guide
Real-time QA Validation Jobs Trends in Cashel, Ireland (Graphical Representation)
Explore profound insights with Expertini's real-time, in-depth analysis, showcased through the graph below. This graph displays the job market trends for QA Validation in Cashel, Ireland using a bar chart to represent the number of jobs available and a trend line to illustrate the trend over time. Specifically, the graph shows 287 jobs in Ireland and 3 jobs in Cashel. This comprehensive analysis highlights market share and opportunities for professionals in QA Validation roles. These dynamic trends provide a better understanding of the job market landscape in these regions.
Great news! Test Triangle is currently hiring and seeking a QA Validation Specialist – Lab 6 mth contract to join their team. Feel free to download the job details.
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An organization's rules and standards set how people should be treated in the office and how different situations should be handled. The work culture at Test Triangle adheres to the cultural norms as outlined by Expertini.
The fundamental ethical values are:The average salary range for a QA Validation Specialist – Lab 6 mth contract Jobs Ireland varies, but the pay scale is rated "Standard" in Cashel. Salary levels may vary depending on your industry, experience, and skills. It's essential to research and negotiate effectively. We advise reading the full job specification before proceeding with the application to understand the salary package.
Key qualifications for QA Validation Specialist – Lab 6 mth contract typically include Other General and a list of qualifications and expertise as mentioned in the job specification. Be sure to check the specific job listing for detailed requirements and qualifications.
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