We are looking for a Validation Analyst to join our team and support validation activities within a regulated life sciences environment. This role is a great opportunity for someone who enjoys working at the intersection of technology, quality, and business processes, ensuring that systems and solutions meet applicable compliance and validation requirements.
Tasks & Responsibilities:
-Validation Strategy: Develop and implement a validation strategy for digital solutions, ensuring alignment with regulatory requirements, industry best practices, and Roche's internal standards.
-Validation Plans and Protocols: Create validation plans and protocols for digital solutions, including data pipelines and interfaces, automation applications, data-driven models, and statistical tools. Ensure that all validation activities are properly documented and executed according to established procedures.
-Risk Assessment: Conduct risk assessments to identify potential risks associated with the use of digital solutions in a GMP environment. Develop risk mitigation strategies and ensure that appropriate controls are in place.
-Testing and Qualification: Collaborate with cross-functional teams to perform testing and qualification activities for digital solutions, particularly with QA SMEs. This includes executing test cases, analyzing results, and documenting findings.
-Compliance and Documentation: Ensure that all validation activities are compliant with relevant regulatory requirements, such as GMP and data integrity guidelines. Maintain accurate and up-to-date validation documentation, including validation plans, protocols, reports, and change control documentation.
-Continuous Improvement: Drive continuous improvement initiatives related to validation processes, tools, and methodologies. Stay updated with the latest industry trends and regulatory requirements in the field of validation.
-Communication and stakeholder management: Act as an interface between business and IT functionals and as a contact point for business leads in order to launch initiatives, leading and driving the scoping phase.
Requirements:
-Understanding of software development lifecycle models and experience with business/end-user applications.
-Strongge in validation principles and practices in a GMP environment. Experience in validating digital solutions, including Release Management processes and controls, as well as validation of statistical and data-driven models. Familiar with test automation process and development.
-Experience in managing infrastructure through multiple product releases, and have passion for reliability and security. Work with management to set priorities, track operational metrics.
-Demonstrate knowledge of current GxP requirements and documentation standards with the ability to write validation docs.
-Knowledge of pharma and/or cell & gene therapy supply chain processes is a plus.
