Leading Quality Assurance Specialist

Job Opportunity : We are seeking a highly skilled and experienced Validation Expert to join our team.

About the Role : As a Validation Expert, you will be responsible for developing and implementing validation strategies and processes to ensure product quality and reliability throughout the development lifecycle.

Key Responsibilities :

• Validation Strategy and Planning : Develop and implement validation strategies and processes to ensure product quality and reliability throughout the development lifecycle.
• Cross-Functional Collaboration : Work with development, quality assurance, and other teams to define validation requirements and priorities.
• Regulatory Compliance : Establish validation plans, protocols, and procedures in compliance with FDA, ISO, MHRA standards, and industry best practices.
• Validation Execution : Oversee IQ / OQ / PQ, software validation, and process validation activities, ensuring thoroughness and accuracy.
• Risk Management : Perform risk assessments and develop mitigation strategies to address potential product risks related to validation.
• Process Improvement : Drive continuous improvement initiatives to enhance validation processes, streamline workflows, and increase efficiency.
• Vendor Management : Manage relationships with external vendors and contractors as needed for validation testing services.
• Documentation and Traceability : Ensure end-to-end documentation and traceability of validation activities, including validation plans, test protocols, and reports.
• Communication : Provide regular updates and reports on validation activities to senior management and stakeholders.
• Team Leadership : Lead and manage a team of validation analysts, providing guidance, coaching, and mentorship for their professional growth and development.