Job Title

Job Title - ITQC Consultant - Trace ProjectJob Type - HybridExperience - 7+ YearsJob Description - Role Description – IT QCThe IT Quality Control (IT QC) role is responsible for independently reviewing and verifying that GxP-relevant IT systems are validated, compliant, and fit for intended use. The IT QC ensures that system validation activities, documentation, and controls meet applicable regulatory requirements (e.g., GxP, 21 CFR Part 11, EU Annex 11) and internal quality standards throughout the system lifecycle.Required CompetenciesExperience with validation of IT systems .Training and Completion of the following SOPs and any other SOP's relevant to this roleQ187219, Manage IT Systems including digital solutionsQ187655, Manage Information Security in IT Solutions.Q204010, Manage Data Integrity in IT SolutionsQ054929, Good Documentation Practice and Data IntegrityQ0300381, Validation DeviationsQ220205, Change ControlRegulatory & Compliance KnowledgeSolid understanding of GxP principles and regulatory expectations for computerized systemsKnowledge of 21 CFR Part 11, EU Annex 11, data integrity (ALCOA+), and risk-based validationKnowledge of GAMP5 practicesFamiliarity with audits and inspections (internal, vendor, and regulatory)Validation & Quality SkillsExperience with Computer System Validation (CSV) / Computerized System Assurance (CSA)Ability to review and approve validation deliverables (e.g., URS, risk assessments, IQ/OQ/PQ, test evidence, traceability Matrix)Understanding of SDLC, change management, deviation, and CAPA processesStrong attention to detail and documentation accuracy Technical UnderstandingGeneral understanding of IT infrastructure, applications, interfaces, and data flowsAbility to assess system controls related to access management, security, backup, and disaster recoveryExperience with GxP systems (e.g., LIMS, MES, QMS, ERP, clinical or laboratory systems)Analytical & Communication SkillsRisk-based and critical thinking mindsetAbility to identify compliance gaps and propose remediation actionsClear written and verbal communication with IT, QA, business, and vendorsAbility to work independently while collaborating in cross-functional teams