ITQC Consultant - Trace Project ( Hybrid)

Job Title -

ITQC Consultant - Trace Project

Job Type -

Hybrid

Experience -

7+ Years

Job Description - Role Description – IT QC The 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 Competencies Experience with validation of IT systems . Training and Completion of the following SOPs and any other SOP's relevant to this role Q187219, Manage IT Systems including digital solutions Q187655, Manage Information Security in IT Solutions. Q204010, Manage Data Integrity in IT Solutions Q054929, Good Documentation Practice and Data Integrity Q0300381, Validation Deviations Q220205, Change Control Regulatory & Compliance Knowledge Solid understanding of GxP principles and regulatory expectations for computerized systems Knowledge of 21 CFR Part 11, EU Annex 11, data integrity (ALCOA+), and risk-based validation Knowledge of GAMP5 practices Familiarity with audits and inspections (internal, vendor, and regulatory) Validation & Quality Skills Experience 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 processes Strong attention to detail and documentation accuracy Technical Understanding General understanding of IT infrastructure, applications, interfaces, and data flows Ability to assess system controls related to access management, security, backup, and disaster recovery Experience with GxP systems (e.g., LIMS, MES, QMS, ERP, clinical or laboratory systems) Analytical & Communication Skills Risk-based and critical thinking mindset Ability to identify compliance gaps and propose remediation actions Clear written and verbal communication with IT, QA, business, and vendors Ability to work independently while collaborating in cross-functional teams