QA Validation Professional - P2 in Bangalore, भारत
Danaher
On-siteWork from the office
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
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