Company Description
Archimedis Digital is a global professional IT services company focused exclusively on building digital products and solutions for Life Sciences organizations. The team combines deep Life Sciences domain knowledge with strong IT expertise to address complex, cross-functional business challenges. Archimedis Digital partners with clients across the entire digital lifecycle, from strategy through implementation and optimization. Its offerings are designed to simplify digital transformation, improve efficiency, and support growth for Life Sciences companies. The company fosters a collaborative, innovation-driven environment for technology professionals who want to work close to the Life Sciences industry
About the Role
We are seeking a highly skilled Senior QA Automation Engineer with strong expertise in Tricentis Tosca Automation and GxP Computer System Validation (CSV). The ideal candidate will have hands-on experience in designing and implementing automation frameworks using Tosca while ensuring compliance with regulatory requirements in Life Sciences, Pharmaceutical, Biotechnology, or Healthcare environments.
This role requires a blend of automation expertise, functional testing knowledge, and validation experience to support regulated applications and digital transformation initiatives
Key Responsibilities
Test Automation
- Design, develop, and maintain automated test solutions using Tricentis Tosca
- Build and execute automated regression, integration, system, and end-to-end test suites
- Develop reusable Tosca modules, test cases, and test data management strategies
- Integrate Tosca automation with CI/CD pipelines and test management tools
- Analyze test results, identify defects, and work closely with development teams for resolution
- Optimize automation coverage and improve testing efficiency across projects
Functional Testing
- Review and analyze business and functional requirements
- Create and execute test scenarios, test cases, and test scripts
- Perform System Testing, Integration Testing, Regression Testing, and User Acceptance Testing support
- Participate in defect triage, root cause analysis, and quality improvement initiatives
GxP Validation & Compliance
- Support validation activities for regulated systems in compliance with GxP requirements
- Author and review validation deliverables including:
- Validation Plans
- Risk Assessments
- Functional Risk Assessments (FRA)
- IQ/OQ/PQ Protocols
- Traceability Matrix
- Validation Summary Reports (VSR)
- Ensure compliance with:
- FDA 21 CFR Part 11
- EU Annex 11
- GAMP 5
- Data Integrity (ALCOA+) principles
- Participate in audits and inspection readiness activities
- Support CSA (Computer Software Assurance) and risk-based validation approaches
Stakeholder Collaboration
- Collaborate with Business Analysts, Product Owners, Developers, Validation Leads, and Quality teams
- Participate in requirement reviews and provide testability recommendations
- Mentor junior testers and contribute to automation best practices
Mandatory Skills
Automation
- 5–6 years of software testing experience
- Minimum 3+ years of hands-on experience with Tricentis Tosca
- Strong experience in:
- Tosca Commander
- Model-Based Test Automation
- Test Case Design
- Test Data Management
- API Testing using Tosca
- Web Application Automation
- Experience in automation framework design and maintenance
- Knowledge of CI/CD concepts and integration
GxP Validation
- Strong experience in Computer System Validation (CSV) within regulated environments
- Hands-on experience preparing and reviewing validation documentation
- Understanding of FDA, EMA, and GAMP guidelines
- Experience with risk-based validation and CSA approaches
Functional Testing
- Strong knowledge of SDLC, STLC, Agile, Waterfall, and V-Model methodologies.
- Experience in requirements analysis, test design, execution, and defect management.
- Excellent analytical and troubleshooting skills
Preferred Skills
- Experience in Life Sciences, Pharmaceutical, Biotechnology, Medical Device, or Healthcare domains
- Experience with:
- HP ALM / Quality Center
- JIRA
- Azure DevOps
- SAP Validation
- Salesforce Validation
- Laboratory Systems (LIMS, ELN)
- Manufacturing Systems (MES)
- Exposure to API testing and database validation
- Knowledge of CSA (Computer Software Assurance) principles
- Tosca Certification (AS1/AS2 or higher) is preferred
Salary: Commensurate with current experience
Job Location: Chennai/Pune
