• 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 F DA guidance's and industry standards (i.e., GAMP). Strong understanding on 21 CFR Part 11 nd Risk Based Approach with the ability to guide the project teams
• Possesses strong communication skills to interact with business stake holders (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.
• Possesses strong communication skills to interact with business stake holders (Technology Leader, Project Manager, Business Owner & Business users / SME) and interpret business rules and requirements and documents them for software development.
• Should be able to handle and guide multiple GxP projects
• Ability to work with project team to facilitate interaction between Project team and Business Stake holders.
• 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