Descripción
The Validation Specialist is responsible for creating and maintaining validation documents, such as internal validation protocols, Installation Qualification (IQ), Operational Qualification (OQ), and Change Controls, to ensure that Optel systems comply with industry standards. This role requires expertise in documentation, a drive for innovation through continuous improvement, and the ability to collaborate with internal teams and clients to ensure project validation and quality control.Tasks:Validation documentation and management:Manage the validation template lifecycle: maintain, optimize, and automate existing templates (using MS Office Suite and VBA macros) to increase efficiency while ensuring regulatory compliance, such as Good Automated Manufacturing Practice (GAMP), FDA 21 CFR Part 11, and EU Annex 11.Identify and implement continuous improvement opportunities, including leveraging Artificial Intelligence tools to streamline document drafting and review processes.Review and understand system updates, including new releases and hotfixes, to determine the impact on validation documents.Generate validation documents for clients based on the functional and design specifications of the projects.Execute internal validation protocols as needed to ensure system functionality.Risk Analysis and Quality Improvement:Identify potential risks associated with validation activities and develop mitigation strategies.Lead root cause investigations for validation discrepancies and implement corrective actions for continuous quality improvement.Collaboration and Expertise:Partner with various internal departments to deliver validation documentation at specific stages of project development.Collaborate closely with the internal team and clients to provide expert guidance on validation strategies and best practices.Work closely with the quality assurance (QA) team to ensure that validation activities are in line with internal quality systems and external regulatory requirements