QA Validation Professional – P2

Radiometer; Bengaluru; Presencial; INR 1.200.000 - 2.400.000; Jornada completa

Descripción de la vacante

Cepheid in Bengaluru is seeking a QA Validation Professional to support software validation activities in a regulated environment. The role emphasizes design controls, risk management, and compliance with FDA/ISO regulations, reporting to the Associate QA Manager within Cepheid - Software Test Engineering - QA.

You will validate Product Software Systems and Computer Systems, manage VMPs and validation deliverables, and collaborate across Software Engineering to ensure high-quality, compliant

Formación

• 3+ years of CSV and/or Product Software Validation in a regulated environment.
• Strong understanding of FDA regulations, 21 CFR Part 11, EU Annex 11, GAMP 5, ISO standards.
• Hands-on validation and testing in Windows environments, web applications, and SQL analysis.
• Excellent communication and leadership; ability to mentor others and lead small to medium validation projects.

Responsabilidades

• Validate Product Software Systems and Computer Systems, including planning, execution, review, and documentation of validation activities.
• Create, review, and manage validation deliverables: VMPs, risk assessments, protocols, test plans, traceability matrices, validation reports.
• Ensure compliance with internal procedures and regulatory requirements.
• Design, execute, and review functional, integration, and User Acceptance Testing (UAT).
• Analyze test results, generate validation evidence, and support validation report completion per SOPs.
• Record, investigate, verify, and report software defects; ensure accurate representation of requirements and timely resolution.
• Collaborate with Software Engineering and cross-functional teams to identify and resolve design issues and defects.
• Manage documentation changes via document control system; conduct test design reviews and risk assessments; support Product Lifecycle and DBS-driven improvements.

Conocimientos

CSV experience

Regulatory knowledge

SQL

Windows testing

Communication skills

Mentoring

Educación

BE/BS in CS/biology/biomedical

Herramientas

Windows environments

Document control system

Descripción del empleo

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Cepheid, one of Danaher's 15+ operating companies, our work saves lives—and we are all united by a shared commitment to innovate for tangible impact. You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life. At Cepheid, we are passionate about improving health care through fast, accurate, molecular diagnostic systems and tests. As a member of our team, you'll get to make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development. Our mission drives us to develop groundbreaking solutions for the world's most complex health challenges. Together, we bring more change to the world. Learn about the Danaher Business System which makes everything possible.

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.

In this role, you will have the opportunity to:

• 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.

The essential requirements of the job include:

• 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.
• It would be a plus if you also possess previous experience in:
  • 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.

Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com.

Danaher is a leading global life sciences, biotechnology, and diagnostics innovator, helping to solve many of the world's most important health challenges, ultimately improving quality of life for billions of people today, while setting the foundation for a healthier, more sustainable tomorrow.

The Danaher ecosystem is made up of more than 15 businesses united by a shared commitment to innovate for tangible impact.

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