CSV Analyst

Responsible for managing and overseeing IT Computerized System Validation (CSV) functions across all Lupin sites. Ensures validation, compliance, and lifecycle management of GxP computerized systems as per regulatory and internal requirements.

1. Computerized System Validation (CSV)

• Perform and oversee Computerized System Validation activities in compliance with GAMP 5, 21 CFR Part 11, EU Annex 11, WHO Annex 5, and internal approved policies and procedures.

• Ensure all GxP computerized systems are appropriately validated and maintained throughout their lifecycle.

• Monitor and track ongoing CSV activities across sites.

2. Preparation of Validation Deliverables

Responsible for preparation (but not limited to) the following validation documents:

• Validation Protocol (VP)
• Validation Summary Report (VSR)
• System Release Certificate (SRC)
• Traceability Matrix

3. Review of Validation Deliverables

Responsible for review and approval (but not limited to) the following:

• GxP Assessment, EDC Assessment, and Vendor Audit reports
• User Requirement Specification (URS)
• Functional Requirement Specification (FRS)
• Design / Configuration Specification (DCS)
• Validation Test Scripts (IQ, OQ, PQ)
• Risk Assessment documentation

4. Compliance & Governance

• Ensure compliance with cGMP, GxP, and other applicable regulatory requirements, including EH&S requirements.
• Ensure strict adherence to Good Documentation Practices (GDP) for all CSV-related documentation.
• Handle Change Controls, Deviations, CAPAs, Events, and Incidents related to validated GxP computerized systems.
• Conduct Gap Assessments and lead remediation activities.

5. System Lifecycle Management

• Maintain indexing and inventory of validated GxP computerized systems.
• Coordinate retirement (decommissioning) of validated computerized systems, where applicable.
• Coordinate and ensure periodic review of validated systems as per defined procedures.

6. Coordination & Collaboration

• Coordinate with vendors, system owners, and respective in-charges and report status to IT designee/responsible persons.
• Work closely with Site & Corporate Quality, Site IT, and Corporate IT teams for validation and implementation of GxP computerized systems.
• Ensure compliant implementation of IT policies and procedures relating to GxP systems.

7. Training & People Management

• Complete self-training on relevant SOPs and ensure training compliance of team members.
• Provide training to site personnel on Computerized System Validation in line with regulatory guidelines.
• Supervise and guide team members in execution of CSV activities.

8. Audits & Management Reporting

• Support regulatory inspections and audits; prepare and implement mitigation plans as required.
• Participate in site management review meetings and provide updates on ongoing CSV activities and action plans.
• Report any quality concerns or improvement opportunities to management.

9. Additional Responsibilities

• Perform any other responsibilities as assigned by management, aligned with CSV and compliance objectives.

Minimum 3 - 5yrs of experience in CSV