Software Tester

Key Responsibilities

• Plan and execute Computer System Validation (CSV) activities for GxP-regulated systems

• Prepare and review validation documents including:

• Validation Plans (VP)

• User Requirements Specifications (URS)

• Functional & Design Specifications (FS/DS)

• Risk Assessments

• IQ, OQ, PQ protocols and reports

• Traceability Matrix (RTM)

• Ensure compliance with FDA, EMA, GAMP 5, and internal quality standards

• Support validation of systems such as LIMS, QMS, MES, ERP, EDMS, and laboratory instruments

• Perform risk-based validation approaches

• Support change control, deviation management, and periodic reviews

• Participate in audits and inspections; provide CSV support and documentation

• Collaborate with IT, Quality, Engineering, and business stakeholders

⸻

Required Qualifications

• Bachelor’s degree in Engineering, Computer Science, Pharmacy, Life Sciences, or related field

• 1–6 years of experience in CSV within regulated industries (Pharma, Biotech, Medical Devices)

• Strong understanding of:

• GxP regulations

• FDA 21 CFR Part 11

• EU Annex 11

• GAMP 5

• Experience with validation documentation and audit support

• Good analytical, documentation, and communication skills

⸻

Preferred Skills

• Experience with cloud/SaaS validation

• Knowledge of SDLC and Agile environments

• Familiarity with data integrity principles (ALCOA+)

• Experience in vendor assessment and supplier audits