QA Validation Professional - P2 in Bangalore, भारत

Cepheid, a Danaher operating company, seeks a QA Validation Professional to support software validation activities for molecular diagnostic systems. The role involves design control, risk management, and regulatory compliance under FDA and ISO standards, reporting to the Associate QA Manager in Bengaluru on an onsite basis.

Responsibilities

• Plan, execute, and document validation activities for product software and computer systems
• Create and manage validation deliverables including VMPs, risk assessments, protocols, and traceability matrices
• Design, execute, and review functional, integration, and user acceptance testing activities
• Record, investigate, and report software defects; collaborate with engineering teams on issue resolution
• Manage documentation changes, conduct design reviews, and drive quality improvements using DBS tools

Requirements

• BE/BS degree in Computer Science, Biology, Biomedical Engineering, or related field
• 3+ years Computer System Validation (CSV) or Product Software Validation in regulated environments
• Strong knowledge of FDA regulations, 21 CFR Part 11, EU Annex 11, GAMP 5, and ISO standards
• Hands-on experience with Windows environments, web application testing, SQL, and defect management
• Excellent communication, analytical, and leadership abilities with independent project capability
• Ability to quickly learn new technologies and mentor team members