The role of a Validation Lead involves overseeing the planning, coordination, and execution of validation activities within an organization. This includes ensuring compliance with regulatory standards, internal quality policies, and project requirements.
Key responsibilities include developing, managing, and executing validation plans, protocols (IQ, OQ, PQ), and reports in compliance with regulatory and industry standards. The candidate will also lead validation efforts for HVAC equipment, facilities, lab equipment, and utilities systems.
Maintenance of up-to-date knowledge of applicable regulations is essential, and the Validation Lead must ensure that validation activities align with these standards. This involves identifying and resolving validation-related issues, providing risk assessments, and remediation plans as needed.
The successful candidate will oversee the development and training of the validation team, ensuring high standards of competency and compliance. Conducting annual reviews for the team and providing technical validation support for tender processes are also key responsibilities.
Furthermore, the Validation Lead will drive continuous improvement initiatives within validation processes to enhance efficiency and compliance. Acting as the primary point of contact for internal and external audits concerning validation activities is also a critical aspect of the role.
Essential skills and qualifications include relevant engineering experience, proficiency in Microsoft Office, excellent communication skills, and a confident decision-making ability. Additionally, a strong understanding of technical writing and documentation is required.