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