Senior Executive - CQA CSV

USV; Maharashtra; On-site; INR 1,400,000 - 2,000,000; Full time

Job summary

USV is seeking an experienced Quality Assurance / Computer System Validation professional to oversee regulatory compliance of GxP-impacting computerized systems. You will review CSV/CSA documentation across the lifecycle and participate in audits with regulators, customers, and external vendors.

The role requires 5–8 years of hands-on QA/CSV experience in a regulated pharma environment, with strong knowledge of GAMP5, CFR 11, and ICH guidelines; expertise in TrackWise and ValGenesis is essential.

Qualifications

• 5–8 years of hands-on experience in QA/CSV within a regulated pharmaceutical manufacturing environment.
• In-depth knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, USFDA, MHRA, WHO and ICH guidelines.
• Hands-on expertise in validating automated systems including PLC/SCADA, LIMS, CDS, ERP (SAP), WMS and eQMS tools.
• Experience operating TrackWise Digital QMS (eQMS) and ValGenesis.
• Strong RCA, CAPA design, risk assessments (FMEA) and vendor qualification.
• Excellent technical writing for validation protocols/reports and audit-facing communication.

Responsibilities

• Monitor regulatory compliance of all GxP-impacting computerized systems across USV.
• Review/approve CSV and CSA documentation through system life cycle.
• Lead audits with regulators and customers to explain validation activities.
• Drive SOP/policy lifecycle for validation to keep systems in a validated state.
• Oversee deviations, change controls, investigations, CAPA and risk management.
• Coordinate vendor evaluations and outsourced validation activities.
• Provide site-wide CSV training and cross-functional coordination.

Skills

Validation expertise

Audit readiness

Vendor oversight

Regulatory compliance

Cross-functional collab

RCA & CAPA

Documentation writing

Education

B.Pharm / M.Pharm / M.Sc / B.E. / B.Tech

Tools

TrackWise eQMS

ValGenesis

SAP ERP

LIMS

WMS

PLC/SCADA validation

Job description

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:

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.

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

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

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.