About us : HCLTech is a global technology company, home to more than 223,400 people across 60 countries, delivering industry-leading capabilities centered around digital, engineering, cloud and AI, powered by a broad portfolio of technology services and products. We work with clients across all major verticals, providing industry solutions for Financial Services, Manufacturing, Life Sciences and Healthcare, Technology and Services, Telecom and Media, Retail and CPG, and Public Services. Consolidated revenues as of 12 months ending June 2023 totaled $12.8 billion. To learn how we can supercharge progress for you, visit hcltech.com. Website - http://www.hcltech.com
Job Details :
- Years of Non-Product Software Validation engineer with Manufacturing background (Medical devices or Diagnostics)
- Non-Product software validation for Manufacturing Equipments as per Regulatory standards (FDA, ISO requirements)
- Prepare, review functional requirements, design and testing documents.
- Prepare, review of SLC deliverables (Validation plan, change requests, User requirements specification, Functional requirement specification, function risk assessment, installation qualification, operational qualification, performance qualification, traceability matrix, project release notes, system certification summary)
- Execute validation activities in computerized system and ensure 21 CFR part 11 compliance. Knowledge in GAMP.
- Preparing trace matrix to ensure requirements are tested to meet the software intended use.
- Preparing risk assessment for functional requirement and provide testing strategy, implementing technical & procedural controls as part of mitigation.
- Preparing SOP/Work instruction for equipments and software-based systems.
