QA Specialist (Fully Remote)

A leading global Pharmaceutical organisation is currently seeking an experienced QA Specialist to support a large portfolio of global validation projects.

This is a fully remote position, with working hours aligned to a USA time zone.

Role Overview

The QA Specialist will provide quality oversight across validation activities, ensuring compliance with GxP regulations, data integrity requirements, and internal quality standards.

While the primary focus is on QA validation and governance, experience in Computer System Validation (CSV) would be a strong advantage. The role centres on documentation review, risk-based quality oversight, and ensuring robust lifecycle compliance across systems and processes.

Key Responsibilities

• Provide QA oversight of validation activities across global projects, ensuring compliance with GxP and internal quality standards
• Review and approve key validation deliverables, including:
• Validation Plans & Reports
• Requirements & Traceability Matrices
• Test Plans, UAT documentation, and test results
• Data migration and system lifecycle documentation
• Ensure compliance with data integrity principles, 21 CFR Part 11, and Annex 11 requirements
• Provide risk-based QA oversight across the validation lifecycle
• Support change control, deviation management, and CAPA processes
• Identify and manage GxP risks across validation and system activities
• Support audit and inspection readiness, ensuring documentation is audit-ready
• Provide guidance to cross-functional teams on QA processes, validation standards, and data integrity expectations
• Collaborate with validation and IT teams, with exposure to CSV activities where applicable
  
  

Requirements

• Degree in a scientific, engineering, or related discipline
• 5+ years’ experience in QA validation within a GxP-regulated pharmaceutical environment
• Strong experience in validation lifecycle documentation review and approval
• Solid understanding of GxP, data integrity, and regulatory requirements
• Knowledge of 21 CFR Part 11 and Annex 11
• Experience supporting global or complex validation projects
• Strong stakeholder engagement and communication skills
  
  

Nice to Have

• Experience with Computer System Validation (CSV) (QA oversight or hands-on)
• Exposure to systems such as SAP, LIMS, or ELN
• Experience in API, biologics, or OSD manufacturing environments
• Previous experience providing QA oversight on CSV or IT validation activities