Quality Assurance Analyst

We are seeking a meticulous and proactive Quality Assurance Analyst to drive quality and compliance initiatives, with a strong emphasis on Computer System Validation (CSV) and alignment with the Software Development Life Cycle (SDLC). This role ensures that systems supporting regulated activities are validated, compliant, and fit for purpose, in line with GxP and other regulatory standards.

🎯 Key Responsibilities

• Lead and manage validation activities for GxP-relevant systems in accordance with CSV best practices and regulatory requirements (e.g., FDA 21 CFR Part 11, Annex 11).
• Develop and execute test plans, test cases, and protocols supporting validation efforts throughout the SDLC.
• Collaborate with cross-functional teams including IT, Quality, Development, and Business Units to ensure compliance from system concept through retirement.
• Support periodic reviews, risk assessments, and change control processes for validated systems.
• Identify and document deviations, non-conformances, and CAPAs, ensuring timely resolution.
• Author and review SDLC deliverables including Requirements Specifications, Traceability Matrices, Validation Plans, Test Scripts, and Summary Reports.
• Assist in audits and inspections by providing validation documentation and regulatory defense, when needed.

🧠 Qualifications & Experience

• Bachelor's degree in Computer Science, Life Sciences, Engineering, or a related discipline.
• 3+ years of experience in QA with a strong foundation in CSV and SDLC methodologies.
• In-depth knowledge of GxP regulations, risk-based validation, and data integrity principles.
• Experience working with system lifecycle documentation and validation within the pharmaceutical, biotech, or medical device industries.
• Familiarity with tools such as Jira, HP ALM, or other testing and requirements management platforms.
• Excellent analytical, documentation, and communication skills.