System Validation Lead - GxP

Job Title

• 10+ years' experience in computer system validation or quality management or business analysis in GxP application area
• Has working experience in any one or two of the following domains - clinical development and supply chain, drug discovery, MES, QMS, LIMS, data integrity platforms
• Guide the project team with the right set of applicable project deliverables based on project type and category while catering to the SDLC
• Application of FDA guidance's and industry standards (i.e., GAMP). Strong understanding on 21 CFR Part 11 and risk based approach with the ability to guide the project teams
• Possesses strong communication skills to interact with business stakeholders (technology leader, project manager, business owner & business users / SME) and interpret business rules and requirements and documents them for software development.
• Expertise in documenting / guiding various SDLC deliverables including requirements specification/user stories, criticality assessment, test plan, design documentation, validation plan, risk assessment, validation strategy / test planning, validation / test summary, requirement trace matrix.
• Should be able to handle and guide multiple GxP projects
• Ability to work with project team to facilitate interaction between project team and business stakeholders.
• Ability to manage and provide guidance / train the team on policies, end to end SDLC process, procedure and tools
• Trains the project team on the relevant procedures associated with different SDLC processes and tools
• Strong in project management tools like JIRA
• Manage project priorities based upon identified risks.
• Performs periodic review
• Performs CAPA management, deviations management