Software Validation Specialist

As Software Validation Specialist located in the Pune office you will ensure that software products meet quality and regulatory standards by designing and executing protocols and procedures in a clinical environment. Responsibilities may include creating test plans, conducting tests, documenting results, analyzing data, and ensuring compliance with industry regulations. Strong analytical skills, attention to detail, and knowledge of validation methodologies and regulatory requirements are preferred for this role. Preferred background in nursing or clinical experience.

• Develop validation plans and protocols: Create comprehensive plans outlining the validation approach and specific procedures for testing software products.
• Execute validation tests: Conduct tests according to the defined protocols, which may involve functional testing, usability testing, and security testing.
• Document test results: Record test outcomes, including any defects or deviations from expected behavior, in a clear and organized manner.
• Analyze test data: Analyze test data to identify patterns, trends, and areas for improvement, and making recommendations for adjustments or enhancements to the software.
• Ensure compliance: Ensure that validation activities comply with relevant industry standards and regulations, such as FDA regulations for medical devices or ISO standards for quality management.
• Collaborate with cross-functional teams: Working closely with software developers, quality assurance engineers, regulatory affairs specialists, and other stakeholders to coordinate validation activities and address issues as they arise.
• Provide documentation and reports: Generate documentation and reports summarizing validation activities, results, and conclusions for internal use and regulatory submission.
• Participate in audits and inspections: Support audits and inspections by regulatory agencies or external auditors by providing documentation, responding to inquiries, and demonstrating compliance with validation requirements.
• Continuous improvement: Identify opportunities to improve validation processes, tolls, and methodologies to enhance efficiency, effectiveness, and compliance.
• Training and mentoring: Provide guidance and training to colleagues on validation best practices, procedures, and tools to ensure consistent and thorough validation across projects and teams.

• Education and Experience: Bachelors degree (or equivalent experience) in Radiation Oncology or equivalent technical field plus 2-5 years experience
• Experience working in a clinical or nursing environment
• Experience working with Varian software and tools (such as ARIA) or very similar competing technologies
• Strong attention to detail and a commitment to ensuring data integrity.
• Ability to work independently and collaboratively within a team.
• Experience Level with Business Tools: Proficient in utilizing business tools such as: E-mail, Microsoft Word, Excel, and PowerPoint.
• Experience with HCM (e.g., Workday) or equivalent ERP product and productivity software desired.