Role description
- We are seeking an experienced IT System Validation tester of lab applications used in pharma, bioanalytical and clinical research. The ideal candidate will have hands-on experience with LIMS in a regulated GxP environment, ensuring systems are compliant with FDA, EMA, MHRA, and other applicable regulatory requirements.
- Key Responsibilities:
- Plan, author, and execute validation activities for LIMS and SampleManager including IQ, OQ, PQ protocols, and 21 CFR Part 11 compliance assessments.
- Develop and review validation documentation: Validation Plans, URS, FRS, Risk Assessments, Traceability Matrix, Validation Summary Reports, etc.
- Ensure LIMS and associated modules are validated in compliance with GAMP 5, GxP, and data integrity principles.
- Collaborate with QA, IT, Laboratory, and Clinical teams to gather requirements, assess risks, and ensure system suitability.
- Participate in change control activities, periodic reviews, and system upgrades from a validation perspective.
- Support audits and inspections by regulatory authorities or sponsors, including preparation of validation documentation and addressing observations.
- Review and verify data integrity and audit trail functionality for compliance with applicable regulatory standards.
- Provide guidance and training to stakeholders on validation best practices and compliance.
- Required Qualifications:
- Bachelor s or Master s degree in Life Sciences, Computer Science, IT, or related field.
- Minimum 3+ years of experience in IT Validation or Computer System Validation (CSV) in a regulated life sciences environment.
- Hands-on experience validating LIMS in bioanalytical or clinical settings.
- Strong understanding of FDA 21 CFR Part 11, EU Annex 11, GAMP 5, ALCOA+ principles, and ICH E6 (R2).
- Experience with bioanalytical workflows, clinical sample management, and LIMS data structures.
- Familiarity with audit trail review, electronic signature validation, and data lifecycle management.
- Strong technical documentation and project management skills.
- Preferred Qualifications:
- Prior experience in CROs, clinical research organizations, or pharmaceutical/biotech companies.
- Experience with integration of LIMS with other lab or enterprise systems (e.g., CDS, ELN, CTMS).
- Validation or QA certifications a plus.
- Must Have: High proficiency in Japanese language ( both verbal and written)
Skills
software testing,lims,gxp,iq,oq,21 cfr part 11,gamp 5,
About UST
UST is a global digital transformation solutions provider. For more than 20 years, UST has worked side by side with the world’s best companies to make a real impact through transformation. Powered by technology, inspired by people and led by purpose, UST partners with their clients from design to operation. With deep domain expertise and a future-proof philosophy, UST embeds innovation and agility into their clients’ organizations. With over 30,000 employees in 30 countries, UST builds for boundless impact—touching billions of lives in the process.
