Quality Assurance Specialist

About the role

The Quality Assurance Specialist will lead Computer System Validation (CSV) activities for new and modified GxP‑regulated systems, ensuring compliance with FDA 21 CFR Part 11, EU Annex 11 and ISO 27001. You will work in a fast‑paced, cross‑cultural environment supporting pharma, biotech and clinical‑trial operations.

Key responsibilities

• Oversee CSV lifecycle for all GxP computerized systems, from planning to validation deliverables.
• Maintain data‑integrity principles and ensure systems stay validated and compliant.
• Plan and execute audits of IT vendors, review findings, and drive corrective and preventive actions (CAPAs).
• Lead root‑cause analysis sessions with cross‑functional SMEs and approve CAPAs.
• Conduct supplier qualification reviews and risk assessments for new technologies, including AI solutions.
• Write and approve SOPs and regulatory documentation (risk control matrices, test scripts, issue reports).
• Handle day‑to‑day compliance operations such as vendor questionnaires and audit metrics.

Required profile

• Minimum 6 years of quality assurance experience in regulated environments.
• Hands‑on experience with GxP, FDA 21 CFR Part 11, EU Annex 11 or ISO 27001.
• Proven background in Computer System Validation, audit management, CAPA, SOPs, change control and risk assessment.
• Bachelor’s degree in Information Technology or a related field.
• Strong written and spoken English communication skills.

Required skills

• GxP
• FDA 21 CFR Part 11
• EU Annex 11
• ISO 27001
• Computer System Validation (CSV)
• Validation Packages, Documentation and Lifecycle
• Audits and CAPA management
• SOP development
• Change Control
• Risk Assessment
• Microsoft Office (Word, Excel, PowerPoint, MS Project)
• Database software
• Veeva
• LIMS