Quality Lead/ Lead Validation Engineer - 5122

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Requirements:

• Bachelor's degree and relevant GxP work experience.
• 8-10 years of validation activities experience.
• Proficiency in Microsoft Office applications.
• Experience performing Quality Assurance functions related to Clinical Computerized Systems / Infrastructure.
• Familiarity with FDA / MHRA regulations.
• Knowledge of GAMP and Agile validation lifecycle methodologies.
• Experience with computerized quality management systems.
• Expertise in FDA regulations, ISPE guidelines, and ISO standards, including Good Documentation Practice.
• Strong communication skills to interact with all levels of the organization.
• Attention to detail and ability to work independently.

Responsibilities:

• Support the QISM group at the Client, focusing on IT Infrastructure and Clinical Operations.
• Work closely with operational functions to provide oversight of computerized system implementation, maintenance, and retirement.
• Review and approve computerized system lifecycle documentation.
• Provide expertise in Part 11/Annex 11, and data integrity to stakeholders.
• Participate in system implementation teams to guide on validation strategy and lifecycle activities using a risk-based approach.
• Identify and define high risk areas to focus on patient safety, product quality, and data integrity.
• Consult with team members to ensure compliance and manage risks.
• Participate in Periodic Review activities of Computerized Systems.
• Support regulatory inspection preparedness as needed.