Roles & Responsibilities:

• Bachelor’s degree in computer science, Information Technology, Electronics Engineering, or a related field.
• Minimum 5-8 years of experience in software validation, preferably withinthe medical device, pharmaceutical, or regulated healthcare industries.
• Strong understanding of software development lifecycle (SDLC) methodologies, validation planning, risk management, and quality assurance principles.
• Experience in handling SW development and verification tools.
• Good exposure to FDA regulations (21 CFR Part 11, Part 820), ISO 13485, EU MDR, GAMP 5, and other relevant standards for software lifecycle and validation.
• Experience with computerized system validation (CSV) approaches for non-product applications.
• Proficiency in authoring validation documents as per SOP or work instruction.
• Responsible for SW Validation planning, requirement gathering, Risk assessment, protocol development and test execution.
• Work with cross functional team and SME to understand the intended use and prepare the above documentation.

• Bachelor’s degree in computer science, Information Technology, Electronics Engineering, or a related field.
• Minimum 5-8 years of experience in software validation, preferably withinthe medical device, pharmaceutical, or regulated healthcare industries.
• Strong understanding of software development lifecycle (SDLC) methodologies, validation planning, risk management, and quality assurance principles.
• Experience in handling SW development and verification tools.
• Good exposure to FDA regulations (21 CFR Part 11, Part 820), ISO 13485, EU MDR, GAMP 5, and other relevant standards for software lifecycle and validation.
• Experience with computerized system validation (CSV) approaches for non-product applications.
• Proficiency in authoring validation documents as per SOP or work instruction.
• Responsible for SW Validation planning, requirement gathering, Risk assessment, protocol development and test execution.
• Work with cross functional team and SME to understand the intended use and prepare the above documentation