Life Science Consultant, LIMS QA Expert

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Life Science Consultant, LIMS QA Expert

Position: LIMS QA Expert
Location: Ireland

Mission:
As a LIMS QA Expert, you will ensure the compliance, validation, and quality assurance of Laboratory Information Management Systems (LIMS) in GxP-regulated environments. Your mission is to guarantee that LIMS implementations, upgrades, and operations meet international regulatory standards (21 CFR Part 11, EU Annex 11) and company SOPs, while supporting laboratory operations with reliable, validated, and audit-ready systems.
You will collaborate with IT, Quality, and Laboratory teams to oversee validation deliverables, risk assessments, and system lifecycle management, ensuring data integrity and regulatory compliance across the enterprise.

Key Accountabilities:

• Ensure LIMS compliance with GxP, FDA 21 CFR Part 11, EU Annex 11, and Data Integrity principles.
• Review, approve, and maintain validation documentation (URS, FS, DS, IQ, OQ, PQ, Test Scripts, Traceability Matrix).
• Support and/or execute validation activities during new LIMS implementations, upgrades, and data migrations.
• Lead QA oversight for change controls, deviations, CAPAs, and risk assessments related to LIMS.
• Partner with business and IT stakeholders to ensure controlled and compliant system lifecycle management.
• Conduct periodic reviews of LIMS systems and ensure readiness for internal and external audits.
• Provide QA expertise during regulatory inspections, acting as SME for LIMS validation and compliance topics.
• Review and approve LIMS-related SOPs, training materials, and work instructions.

Key Qualifications:
Education & Experience:

• Bachelor's or Master's degree in Life Sciences, Computer Science, Engineering, or a related discipline.
• 3-7 years of experience in QA roles focused on computerized systems, preferably LIMS.
• Hands-on experience with LIMS platforms (e.g., LabWare, LabVantage, SampleManager, Thermo Fisher).
• Experience in computerized system validation (CSV) within a GxP pharmaceutical or biotech environment.
• Proficiency in English (oral and written) is mandatory, additional languages are a plus.

Technical Skills:

• Solid understanding of GxP, GAMP5, CSV, 21 CFR Part 11, Annex 11 requirements.
• Strong knowledge of data integrity and audit trail principles.
• Familiarity with QC-related systems (e.g., ELN, CDS, Empower, LES) is an advantage.
• Experience preparing for and supporting audits/inspections.

Key Competencies:

• Strong analytical, documentation, and problem-solving skills.
• Confident communicator, able to explain QA and validation principles to technical and non-technical stakeholders.
• Structured, detail-oriented, and quality-focused mindset.
• Ability to work independently in a global, remote, and cross-functional environment.

You:

• Are driven by impact, passionate about shaping the future of Life Sciences and healthcare through technology and innovation.
• Believe in open communication, speak up, challenge ideas, and engage in meaningful discussions, even with leadership.
• Focus on solutions, not problems, take a proactive approach, looking for ways to improve rather than assigning blame.
• Own your work, take responsibility and accountability seriously, no matter how challenging the situation.
• Commit to excellence, delivering high-performance results while embracing sustainable practices in everything you do.

We:

• Strive to be the best; our mission is to become the world's leading consulting company, empowering high-performing individuals, regardless of gender or neurotype, to reach their full potential and leave a lasting legacy of diversity, equality, inclusion, and excellence.
• Foster a culture of respect, value integrity, fairness, and the unique contributions of every team member.
• See mistakes as opportunities, embrace challenges, learn from them, and continuously improve.
• Prioritize potential over experience, believe intelligence, values, and growth matter more than the number of years on a résumé.

Contact
If you are driven, innovative, and eager to make an impact in Life Sciences consulting, we would love to hear from you.
To apply, send your application to , including, your:

• CV, motivation letter, and supporting documents (diplomas, certificates, references)
• Availability, including earliest start date
• Salary expectations
• Location preference

We believe in potential, values, and growth-so if this role excites you, let's connect
Your KVALITO Team.