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GXP validation tester

1 month ago

Delhi, India Birlasoft Full time
About Birlasoft:

Birlasoft, a powerhouse where domain expertise, enterprise solutions, and digital technologies converge to redefine business processes. We take pride in our consultative and design thinking approach, driving societal progress by enabling our customers to run businesses with unmatched efficiency and innovation. As part of the CK Birla Group, a multibillion-dollar enterprise, we boast a 12,500+ professional team committed to upholding the Group's 162-year legacy. Our core values prioritize Diversity, Equity, and Inclusion (DEI) initiatives, along with Corporate Sustainable Responsibility (CSR) activities, demonstrating our dedication to building inclusive and sustainable communities. Join us in shaping a future where technology seamlessly aligns with purpose.

- About the Job – We are seeking an experienced GxP Validation Tester with a strong background in software validation and regulatory compliance. The ideal candidate will have hands-on experience in GxP validation processes, excellent domain knowledge, and a working understanding of automation testing.- Job Title – GXP Validation Tester- Experience- 6+years- Location: All BSL- Notice- Immediate or 15 days only

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Key Responsibilities:

- Perform GxP software validation activities, ensuring compliance with regulatory standards such as FDA 21 CFR Part 11 and EU Annex 11.- Develop and execute validation deliverables, including Validation Plans, Test Plans, Test Cases, and Validation Summary Reports.- Collaborate with cross-functional teams to ensure adherence to GxP guidelines throughout the software development lifecycle.- Conduct functional, regression, and risk-based testing to validate system integrity.- Document and manage validation evidence, ensuring traceability and audit readiness.- Support and perform automation testing activities as required (desirable).- Provide insights and recommendations for process improvement and quality assurance.

Required Skills and Qualifications:

- Experience: Minimum 6+ years of overall experience, with at least 3 years in GxP validation.- Strong understanding of GxP principles, regulatory requirements, and validation lifecycle processes.- Experience in creating and managing validation artifacts (e.g., URS, FRS, IQ, OQ, PQ, and traceability matrices).- Good domain knowledge in regulated industries such as pharma, biotech, or life sciences.- Hands-on experience with testing tools and techniques; automation testing experience is a plus.- Familiarity with tools like JIRA, HP ALM, or other test management tools is advantageous.- Strong analytical and communication skills to liaise effectively with stakeholders.

Preferred Qualifications:

- Experience in automation testing frameworks and tools (e.g., Selenium, TestNG).- Certifications such as ISTQB, CSV (Computer Systems Validation), or related credentials.- Knowledge of cloud-based systems validation and modern technologies is a plus.