Technology Quality Specialist I

Overview

Technology Quality Specialist I supporting the Parexel Quality System and technology solution validation activities for clinical trial-related work.

What you'll do

• Act as an ambassador for quality across the business and with customers.
• Collaborate with functional leads to design, implement, and adopt the quality framework for validation and release.
• Support training and adoption program activities tied to infrastructure change control and problem management processes.
• Assist project teams with guidance and expertise for clinical trial and validation activities lifecycle.
• Support compliance monitoring and oversight for technology and related portfolios.
• Help with technology quality issue (QI) management, including classification and oversight of root cause analysis.
• Support planning, coordination, and response activities for audits and inspections.

What you'll need

• Entry-level experience in Computer Technology Quality & Compliance, including CSV/CSA in pharmaceutical and life sciences.
• Understanding of clinical drug development processes across Phase I–IV and regulated GxP manufacturing environments.
• Working knowledge of FDA, EU, and ICH guidance for validation, compliance, and assurance of computerized systems.
• Understanding of GAMP 5 principles for validation and assurance of computerized systems (including AI-enabled applications).
• 2–3 years of relevant experience (noted as required).
• Education to degree level in technology, biological science, pharmacy, or a related health discipline (preferred) or equivalent qualification.
• Proficiency in Microsoft Office Suite and standard desktop tools (including Adobe Acrobat PDF).

Details

• Location: India-Bengaluru-Remote.