รายละเอียดงานThe Validation Senior Manager is responsible for overseeing a team dedicated to validation, ensuring all aspects of validation, testing, and documentation are completed in a timely and efficient manner. This role involves managing and coordinating validation projects, ensuring compliance with GMP regulations, and addressing regulatory issues. The Validation Senior Manager will also ensure that validation strategies are aligned with organizational goals and that quality systems are maintained throughout all processes and strategic activities.
[1]Team Leadership: Lead and manage a team of validation engineers, providing guidance and support to ensure successful project outcomes.
[2]System Development: Develop and maintain the team’s validation system to meet current regulatory requirements, internal global standards, and industry best practices.
[3]Project Management: Oversee all aspects of validation projects, including changes to plants, equipment, processes, and automation/innovation initiatives, ensuring timely completion within budget and resource constraints.
[4]Regulatory Compliance: Ensure the successful delivery of validation requirements for regulatory compliance projects in collaboration with the team.
[5]Process understanding: Deep dive into process control studying typically involves gaining a comprehensive understanding.
[6]Review and Coaching: Perform reviews of all validation work, providing coaching and support to sub-coordinators to ensure quality and accuracy.
[7]Problem Solving and Performance Management: Proactively manage and resolve any constraints or performance issues, ensuring that business unit performance aligns with established targets.
[8]Leadership and Direction: Provide clear leadership and direction to ensure business unit performance aligns with the Business Plan and Quality Management System, meeting all regulatory requirements and codes.
[9]Additional Tasks: Perform additional tasks as assigned
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