Company Name: VARITE India Private Limited

About The Client:

A global qualified services network and part of the Big Four, along with Client, EY, and KPMG, operating across 149 countries worldwide.

Essential Job Functions:
Conduct 21 CFR Part 11 gap assessments for plant and laboratory equipment.
Review computerized systems associated with equipment, including PLC, SCADA, DCS, HMI, Client, EMS, MES, LIMS, and standalone systems.
Assess electronic records, electronic signatures, audit trails, user access, security, backup, recovery, data retention, and system controls.
Evaluate equipment qualification and validation documentation, including URS, risk assessments, IQ/OQ/PQ, functional specifications, and validation reports.
Review equipment configuration, system architecture, interfaces, and critical data flows.
Identify compliance gaps and prepare risk-based remediation plans.
Develop assessment protocols, checklists, gap reports, and CAPA recommendations.
Conduct interviews with Engineering, Production, Quality, IT, and Validation teams.




Support remediation activities and provide guidance on corrective actions.
Ensure alignment with 21 CFR Part 11, EU Annex 11, GAMP 5, GMP, and data integrity principles such as ALCOA+.
Present findings and recommendations to site and project stakeholders.
Review system lifecycle documentation and assess compliance throughout the validation lifecycle.
Assess controls for data creation, modification, review, approval, and archival.
Evaluate system access controls, user roles, privileges, and segregation of duties.
Review audit trail functionality and controls for critical GMP data.
Assess backup, restore, disaster recovery, and business continuity controls for computerized systems.
Review system interfaces and data transfers to identify potential data integrity risks.
Assess legacy computerized systems and identify technical, procedural, and documentation gaps.
Support development of risk-ba

📌 Senior Consultant – Equipment 21 Cfr Part 11 Gap A Bengaluru
🏢 VARITE
📍 Bengaluru