
Validation Strategist
7 days ago
We are seeking a highly skilled Validation Lead to make a significant impact in our organization.
With a preference for minimal disruption, we are looking for someone who can develop and implement effective validation strategies from day one.
Key responsibilities include:
Validation ExcellenceDevelop and implement validation plans, protocols, and procedures to ensure the quality and reliability of products throughout the development lifecycle.
Collaboration & CommunicationCollaborate with cross-functional teams including development, quality assurance, etc. to define validation requirements and priorities.
Regulatory Compliance & ExpertiseEstablish validation processes in compliance with regulatory standards (e.g., FDA, ISO, MHRA) and industry best practices.
Execution, Oversight, & Risk ManagementOversee the execution of validation activities, including IQ/OQ/PQ, software validation, and process validation, ensuring thoroughness and accuracy.
Process Improvement & OptimizationDrive continuous improvement initiatives to enhance validation processes, streamline workflows, and increase efficiency.
Documentation, Traceability, & AuditingEnsure end-to-end documentation and traceability of validation activities, including Validation Plans, test plans, test protocols, test reports, validation reports, trace matrix, Change Management, Periodic reviews, Audit Readiness, etc.
Leadership, Communication, & Team ManagementProvide regular updates and reports on validation activities to Quality Assurance (IT-QA), status to senior management and stakeholders, and raise risks proactively.
Team Development & GrowthLead and manage a team of validation analysts, providing guidance, coaching, and mentorship to ensure their professional growth and development.
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