About the Company

Our client is a prominent pharmaceutical organization operating in a highly regulated GMP environment, emphasizing quality, compliance, and dependable manufacturing and technical operations.

The Role

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

Responsibilities

• Provide QA support and oversight for equipment, automation, and IS validation.
• Review and approve validation documentation in accordance with GMP and regulatory requirements.
• Offer 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.
• Conduct final QA reviews 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

• Minimum of 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.
• Familiarity with statistical tools for activities such as sampling plans and hypothesis testing.
• Experience in the pharmaceutical industry is preferred.
• Background with nonconformances, CAPAs, and Change Control is preferred.
• Strong analytical, decision-making, and risk-based problem-solving skills.
• Excellent communication, documentation, and writing skills.