Danaher
Bengaluru, Karnataka, India Posted 6d ago
Cepheid, a Danaher company, is seeking a QA Validation Professional to support quality systems activities related to software validation with a focus on design control and risk management.
Key Responsibilities
Responsible for the validation of Product Software Systems and Computer Systems, including planning, execution, review, and documentation of validation activities.
Create, review, and manage validation deliverables including Validation Master Plans, risk assessments, protocols, test plans, traceability matrices, and validation reports.
Design, document, execute, and review functional, integration, and user acceptance testing activities and analyze test results in accordance with SOPs.
Record, investigate, verify, and report software defects to ensure accurate representation of software requirements and support timely resolution.
Manage documentation changes through the document control system, conduct test design reviews, and drive quality improvements through stakeholder collaboration.
Requirements
BE/BS degree in Computer Science, Biology, Biomedical Engineering, or related field with 3+ years of Computer System Validation or Product Software Validation experience.
Strong understanding of regulatory requirements including FDA regulations, 21 CFR Part 11, EU Annex 11, and GAMP 5.
Hands-on experience with validation and testing activities including Windows environments, web application testing, and SQL query execution.
Excellent communication, analytical, and leadership skills.
Preferred Qualifications
Experience in Software Development Life Cycle methodologies and validation of systems such as LIMS, MES, ERP, or Cloud platforms.
Computer Software Assurance implementation and risk-based validation approaches.
Experience with AI/ML-enabled applications and cloud-based solutions.
