Senior Executive - CQA CSV

Role Objective: 

To  monitor, and execute end-to-end validation, qualification, and life cycle management of GxP-impacting computerized systems across USV Private Limited, ensuring continuous regulatory compliance, audit readiness, robust data integrity, and strict adherence to internal eQMS standards. 

KEY RESPONSIBILITIES

• Regulatory Compliance & Validation Oversight: Monitor and ensure full regulatory compliance of all GxP-impacting computerized systems installed across USV Private Limited. Review / approve all CSV and CSA/qualification documentation across the system life cycle, using ValGenesis Validation Lifecycle Management System.

• Audit & Inspection Management:  Participate in internal, customer, and regulatory agency audits to explain computer system validation activities, strategies, and compliance frameworks.

• SOP & Policy Lifecycle Management: Drive continuous review, updates, and timely implementation of SOPs and policies related to GxP-impacting computerized systems to maintain systems in a validated state aligned with evolving current regulatory requirements.

• Quality Management & Risk Governance (eQMS): Review and evaluate deviations, change controls, investigations, incidents, quality risk management, and CAPA identified during system qualification or life cycle maintenance using TrackWise Digital Quality Management System (eQMS). Ensure core root cause analysis and corrective actions maintain a compliant state.

• Periodic Reviews & Functional Assessments: Review, and approve periodic reviews of GxP-impacting computerized systems. Assess system capabilities and functionalities against regulatory standards during system evaluations.

• Vendor Management & Project Integration: Participate in technical evaluations, vendor selection, and capability assessments during project procurement phases. Coordinate with external vendors for outsourced CSV activities and end-to-end validation execution.

• Cross-Functional Collaboration & Training: Conduct site-wide training on CSV approaches, system life cycle maintenance, and current regulatory guidelines. Coordinate between corporate functions and USV site teams for seamless validation execution

 Type of Interaction: Internal 

Interaction with:  Site QA/QC Teams, Corporate Quality, Information Technology (IT), Engineering/Automation, Production, and Site Leadership Teams.   

Nature of Interaction:  Cross-functional coordination for validation planning, SOP updates, change control/deviation approvals, eQMS compliance, system lifecycle maintenance, and training. 

Type of Interaction: External 

Interaction with:  Regulatory Inspectors, Customer Auditors, External Validation Vendors, and Software/Hardware System Suppliers. 

Nature of Interaction:  Audit facing for CSV operations, vendor evaluation/audits, technical capability assessments, and managing outsourced validation deliverables. 

JOB REQUIREMENTS

Professional Experience and Relevant Skills

• Experience: 5–8 years of hands-on experience in Quality Assurance / Computer System Validation within a regulated Pharmaceutical manufacturing environment.

• Technical Expertise:

1. In-depth knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, USFDA, MHRA, WHO, and ICH guidelines pertaining to GxP-impacting computerized systems.

2. Hands-on expertise in validating Automated Systems, PLC/SCADA, LIMS, CDS, ERP (SAP), WMS, and eQMS tools.

3. Practical experience operating and managing TrackWise Digital Quality Management System (eQMS) and ValGenesis.

4. Expertise in root cause analysis (RCA), CAPA design, risk assessments (FMEA), and vendor qualification.

• Skills: Strong technical writing for validation protocols/reports, audit-facing representation skills, project coordination, and vendor oversight.

Academic Qualifications 

• Educational Qualification: B.Pharm / M.Pharm / M.Sc / B.E. / B.Tech in Information Technology, Computer Science, or relevant science/engineering disciplines. 

• Certifications (Preferred): Certified Computer System Validation Professional, ISO/GAMP training certifications, or Lead Auditor credentials.