Back
Mid-level niche regulatory role at a known medtech brand in Bangalore increases applicant density moderately.
Highly industry-specific regulatory and GxP expertise limits transferability across industries.
Explicit 5+ years CSV experience and mandatory regulatory standards make hiring filters highly restrictive.
Login to See Your Match Score
Create a free account or log in to unlock your CV match score across:
Lead and execute Computer System Validation (CSV) strategies and protocols ensuring compliance with FDA and global regulations for GxP-regulated systems including ERP, QMS, MES, and manufacturing software.
Manage validation documentation, system lifecycle compliance aligned with GAMP 5, and act as Subject Matter Expert during audits and regulatory inspections related to CSV and data integrity.
Assess system changes, drive validation activities through change control, and coordinate periodic reviews and remediation of validated systems.
Minimum 5+ years experience in Computer System Validation within regulated medical device, pharmaceutical, or biotechnology environment preferred.
Bachelor’s degree in Engineering, Computer Science, Information Systems, Life Sciences, or related technical field required.
Advanced knowledge and hands-on experience with 21 CFR Part 11, Part 820, ISO 13485, ISO 14971, GAMP5, FDA risk-based software validation guidance.
Location: Bengaluru, India office. Advanced English proficiency required for documentation and communication.
Proven leadership in planning, executing, and documenting validation of enterprise and manufacturing GxP systems under FDA and global regulatory frameworks.
Strong understanding of data integrity controls, audit trails, system security principles, and regulatory compliance for software validation.
Experienced in cross-functional collaboration and acting as SME for audits, inspections, with ability to improve CSV processes and support regulatory readiness.