System Validation Lead - GxP

•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