Lead I

4 days ago

Thiruvananthapuram Kerala, India UST Full time

We are seeking an experienced IT Validation Consultant to lead and support the validation of Watson Laboratory Information Management System LIMS used in bioanalytical and clinical research The ideal candidate will have hands-on experience with Watson 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 Watson 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 Watson 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 Thermo Fisher Watson LIMS 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 Watson 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 Knowledge of laboratory processes such as PK TK and biomarker studies Experience with integration of Watson LIMS with other lab or enterprise systems e g CDS ELN CTMS Validation or QA certifications a plus Skills IT Validation Consultant Watson LIMS SampleManager LIMS CSV IQ Oq PQ script exection Protocol creation Risk assement GXP environment GAMP5 21 CFR Part 1q EU guide About Company 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

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