QA Validation Professional - P2

DHR Holding India; Bengaluru; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Cepheid in Bengaluru (IDC) seeks a QA Validation Professional on-site to support software validation activities and design controls in line with FDA/ISO requirements. You will work with cross-functional teams to ensure compliant validation plans, reports, and documentation.

Responsibilities include planning, executing, and reviewing validation tests, managing defects, and maintaining document control while mentoring junior staff.

Qualifications

• BE/BS degree or equivalent in Computer Science, Biology, Biomedical Engineering, or a related field with 3+ years of CSV and/or product software validation experience in a regulated environment.
• Strong understanding of FDA regulations, 21 CFR Part 11, EU Annex 11, GAMP 5, ISO standards, design controls, risk management, and software validation principles.
• Hands-on experience with validation and testing activities, including Windows, web apps, SQL queries, troubleshooting, defect management, and validation deliverables.
• Excellent communication, analytical, and leadership skills with ability to mentor and lead small to medium validation projects.

Responsibilities

• Validate Product Software Systems and Computer Systems including planning, execution, and documentation of validation activities.
• Create, review, and manage validation deliverables such as VMPs, risk assessments, protocols, test plans, traceability matrices, and validation reports.
• Design, document, execute, and review functional, integration, and UAT testing; analyze results and support validation reports.
• Record, investigate, verify, and report software defects; collaborate with Software Engineering to resolve issues.
• Manage document changes, conduct test design reviews and risk assessments, and participate in DBS-driven daily management.

Skills

CSV Validation

Software Testing

Regulatory Compliance

Automation / Manual Testing

Education

BE/BS in CS/Bio/Biomedical Eng

Tools

SQL

Validation Master Plans

Document Control System

Windows Environments

UAT Testing

Job description

Job Summary

The QA Validation Professional is responsible for supporting the quality systems activities related to software validation, with a focus on design control and risk management in accordance with FDA and ISO regulations. This position contributes to the completion of milestones associated with software projects and activities using existing procedures. This position requires a moderate level of guidance and direction and can solve problems and analyze possible solutions using technical experience.

This position reports to the Associate QA Manager and is part of the Cepheid - Software Test Engineering - QA located in IDC, Bengaluru and will be an on-site role.

Responsibilities

• Responsible for the validation of Product Software Systems and Computer Systems, including the planning, execution, review, and documentation of validation activities. Perform duties as an individual contributor and/or team member with 100% hands-on work.
• Create, review, and manage validation deliverables including Validation Master Plans (VMPs), risk assessments, protocols, test plans, traceability matrices, and validation reports. Ensure compliance with internal procedures and applicable regulatory requirements.
• Design, document, execute, and review functional, integration, and user acceptance testing (UAT) activities. Analyze test results, generate validation evidence, and support validation report completion in accordance with SOPs.
• Record, investigate, verify, and report software defects to ensure accurate representation of software requirements and support timely resolution of design and implementation issues. Work closely with Software Engineering and cross-functional teams to support the identification, resolution, and verification of design issues and software defects.
• Manage documentation changes through the document control system, conduct test design reviews and risk assessments, support Product Lifecycle Application Management activities, drive quality improvements through stakeholder collaboration, and actively participate in daily management using DBS tools.

Requirements

• BE/BS degree or equivalent work experience in Computer Science, Biology, Biomedical Engineering, or a related field, with 3+ years of Computer System Validation (CSV) and/or Product Software Validation experience in a regulated environment.
• Strong understanding of regulatory and quality requirements, including FDA regulations, 21 CFR Part 11, EU Annex 11, GAMP 5, ISO standards, design controls, risk management, and software validation principles.
• Hands-on experience with validation and testing activities, including Windows environments, web application testing, SQL query execution and analysis, troubleshooting, defect management, and validation deliverable development.
• Excellent communication, analytical, and leadership skills, with the ability to quickly learn new technologies, drive product quality and customer satisfaction, mentor less experienced team members, and independently lead small to medium validation projects.

Preferred qualifications

• Software Development Life Cycle (SDLC) methodologies (Agile, Waterfall) and validation of systems such as LIMS, MES, ERP, Cloud, or enterprise software platforms.
• Computer Software Assurance (CSA) implementation, risk-based validation approaches, and transition from traditional CSV practices to CSA methodologies.
• AI/ML-enabled applications, cloud-based solutions, Product Lifecycle Management (PLM/ALM) systems, and participation in regulatory inspections or quality audits as a validation subject matter expert.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.