Quality Specialist – Remote (Pharma Validation)

About the role

The company is seeking an experienced Quality Assurance Specialist to provide oversight for global validation projects in a fully remote capacity. The role focuses on ensuring GxP compliance, data integrity and lifecycle governance across pharmaceutical systems.

Key responsibilities

• Provide QA oversight of validation activities across global projects, ensuring compliance with GxP and internal quality standards.
• Review and approve validation deliverables such as Validation Plans, Reports, Requirements & Traceability Matrices, Test Plans, UAT documentation, and test results.
• Ensure data integrity compliance with 21 CFR Part 11, Annex 11 and related data migration and system lifecycle documentation.
• Deliver risk‑based QA oversight throughout the validation lifecycle, supporting change control, deviation management and CAPA processes.
• Identify and manage GxP risks associated with validation and system activities.
• Support audit and inspection readiness by maintaining audit‑ready documentation.
• Provide guidance to cross‑functional teams on QA processes, validation standards and data integrity expectations.
• Collaborate with validation and IT teams, including exposure to Computer System Validation (CSV) activities.

Required profile

• Degree in a scientific, engineering or related discipline.
• 5+ years of experience in QA validation within a GxP‑regulated pharmaceutical environment.
• Strong experience reviewing and approving validation lifecycle documentation.
• Solid understanding of GxP, data integrity principles and regulatory requirements, including 21 CFR Part 11 and Annex 11.
• Experience supporting global or complex validation projects and strong stakeholder communication skills.

Required skills

• Computer System Validation (CSV)
• SAP
• LIMS
• ELN
• Data migration documentation
• UAT documentation