Regulated Industries Validation Specialist

2 weeks ago


Anand, Gujarat, India Birlasoft Full time
About Birlasoft

Birlasoft, a pioneering force where domain expertise and digital technologies converge to redefine business processes. We pride ourselves on our consultative approach, driving societal progress by empowering 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.

We're seeking an experienced Regulated Industries 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.

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.
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.

Salary: $120,000 - $180,000 per annum



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