QA Validation Specialist

About the Company

Our client is a leading pharmaceutical organization operating in a highly regulated GMP environment, with a strong focus on quality, compliance, and reliable manufacturing and technical operations.

Role Description

As a QA Validation Specialist, you will provide quality assurance support and oversight for equipment, automation and information systems validation, quality risk management, and technical changes. You will act as a QA subject matter expert, reviewing and approving validation and change control documentation while ensuring compliance with GMP, Annex 11, Part 11 and relevant regulatory requirements. The role combines quality engineering, risk management, validation, and close collaboration with Engineering, Operations, IT and other QA functions.

Key Responsibilities

• Provide QA support and oversight for equipment, automation and IS validation.
• Review and approve validation documentation in line with GMP and regulatory requirements.
• Provide QA guidance to Operations and technical teams regarding quality policies and procedures.
• Support quality engineering, testing strategies and quality investigations.
• Represent QA in Quality Risk Management (QRM) activities, including FMEA and risk assessments.
• Review and approve technical changes to equipment and Maintenance & Engineering procedures.
• Perform final QA review of technical change controls and coordinate input from relevant QA areas.
• Manage QA responsibilities related to devices and combination products where applicable.
• Ensure compliance with computerized systems requirements, including Annex 11 and 21 CFR Part 11.
• Support and review CAPAs, nonconformances and quality-related activities.

Requirements

• At least 5 years of experience in a GMP environment.
• Proven experience with equipment and automation validation.
• Strong knowledge of GMP, IS validation and computer compliance.
• Experience with FMEA and other risk management tools.
• Experience with statistical tools for activities such as sampling plans and hypothesis testing.
• Experience in the pharmaceutical industry is preferred.
• Experience with nonconformances, CAPAs and Change Control is preferred.
• Strong analytical, decision-making and risk-based problem-solving skills.
• Excellent communication, documentation and writing skills.