ID: 58424
5 - 7 Years
1 Opening
Bangalore

Role description:
Lead I - Software Engineering

Who we are:
At UST, we help the world’s best organizations grow and succeed through transformation. Bringing together the right talent, tools, and ideas, we work with our client to co-create lasting change. Together, with over 26,000 employees in 25 countries, we build for boundless impact—touching billions of lives in the process. Visit us at.

Job Summary

The IT Quality & Compliance Specialist is responsible for ensuring that computerized systems supporting regulated business processes comply with applicable regulatory requirements and industry standards. This role partners closely with IT, Quality, and business stakeholders to implement and maintain compliant, risk‑based processes for system validation, change control, data integrity, and ongoing compliance, with an emphasis on Computer System Validation/Computer Software Assurance (CSA) principles.

Key Responsibilities

IT Quality & Compliance
Ensure computerized systems comply with applicable regulations and standards,



including 21 CFR Part 11, 21 CFR Part 820, EU GMP Annex 11, ISO 9001,ISO 13485 and other applicable global regulations
Support internal and external audits and inspections related to IT systems and validation
Identify, assess, and mitigate compliance and data integrity risks associated with computerized systems
Contribute to the development, review, and maintenance of IT Quality and CSV/CSA policies, procedures and guidance

Computerized Systems Validation / Assurance
Lead or support risk‑based validation and assurance activities using CSA and/or traditional CSV approaches
Develop and review validation deliverables such as:
Validation Plans
Risk assessments (system or functional)
Test strategies and summaries
Ensure validation activities are fit‑for‑purpose, focused on critical functions, and appropriately documented

Change and Lifecycle Management
Review and approve IT syste

📌 It Quality Bengaluru
🏢 UST Global
📍 Bengaluru