GXP Validation Specialist
2 weeks ago
About Birlasoft:
Birlasoft is a powerhouse where domain expertise, enterprise solutions, and digital technologies converge to redefine business processes. We take pride in our consultative 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 legacy.
We are seeking an experienced GxP validation specialist 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.
- The role involves performing GxP software validation activities, ensuring compliance with regulatory standards such as FDA 21 CFR Part 11 and EU Annex 11.
- Developing and executing validation deliverables, including Validation Plans, Test Plans, Test Cases, and Validation Summary Reports.
- Collaborating with cross-functional teams to ensure adherence to GxP guidelines throughout the software development lifecycle.
- Conducting functional, regression, and risk-based testing to validate system integrity.
- Documenting and managing validation evidence, ensuring traceability and audit readiness.
- Performing GxP software validation activities, ensuring compliance with regulatory standards.
- Developing and executing validation deliverables, including plans, test cases, and reports.
- Collaborating with cross-functional teams to ensure adherence to GxP guidelines.
- Conducting functional, regression, and risk-based testing to validate system integrity.
- Documenting and managing validation evidence.
We offer a competitive salary of $120,000 - $180,000 per annum, depending on experience. Our benefits package includes medical insurance, retirement plan, and paid time off. If you're passionate about regulatory compliance and want to make a difference in the industry, apply now.
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