Role description:

• Author, implement and maintain computerized system’s state of validation and compliance throughout its SDLC
• Suggest process improvements or industry standards which could be applied to improve efficiency and compliance adherence
• Author/review of CSV deliverables such as Validation Plan, Requirements Specification, Test Plan, Summary Reports, Requirements Traceability, Operating procedures (SOPs)
• Oversee of delivery timelines for SDLC documents for respective product release
• Administer SDLC deliverables and trainings for SOPs in official repositories
• Author and manage change control in official system
• Support configuration management (define IT asset strategy for new products)
• Support assessments (IT risk assessment, Data privacy, Supplier assessment)
• Support incident and deviation management (requestor/author/contributor)
• Support periodic review process
• Support regulatory inspection and audit activities as needed
• Build compliance knowledge within product team
• Communicate with other stakeholders and team members around ideas and findings relevant for the overall platform
• Operate as part of a self-directed team in carrying out day to day functions and assigning priorities

Skills & Experience:

• The ideal candidate shall have 5+ years working in computer system validation, preferably in a pharmaceutical environment
• Clear understanding of principles, procedures, governance of validation activities in IT controls and system development life cycle
• Preferred to have knowledge of validation of GxP computerized systems within FDA regulated environments with a strong understanding of industry standards and best practices for computer validation such as GAMP 5, 21 CFR Part 11, and applicable predicate regulations
• Ability to think critically and demonstrate risk based approach to validation strategy
• Analytical problem solving skills applied to issue identification and resolution
• Demonstrated ability to establish and maintain collaborative relationships with stakeholders
• Computer system validation, agile software methodology and lean process experience
• Good documentation practice for GMP preferred
• Knowledge of MS Office applications, MS Teams, JIRA and Confluence preferred

‍