Job description:

New Billing, Exclusive, PotentialComputer System ValidationValidating SAP Systems and other manufacturing systems JD- (6 to 10) years experience in Computer System Validation or Quality management or Business Analysis in GxP application areaHas working experience in any one or two of the following domains -Manufacturing and Supply Chain, MESMust have experience in validating SAP systems and integrations to SAP systems in the manufacturing process.Guide the project team with the right set of applicable project deliverables based on project type and category while catering to the SDLCApplication 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 teamsPossesses 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 ToolsTrains the project team on the relevant procedures associated with different SDLC processes and Tools Strong in Project Management tools like JIRAManage Project priorities based upon identified risks.

• To be responsible for providing technical guidance to a team of developers, enhancing their technical capabilities and increasing productivity.
• To conduct comprehensive code reviews, establish and oversee quality assurance processes, performance optimization , implementation of best practices and coding standards to ensure succeful delivery of complex projects.
• To ensure process compliance in the assigned module, and participate in technical discussionsorreview as a technical consultant for feasibility study (technical alternatives, best packages, supporting architecture best practices, technical risks, breakdown into components, estimations).
• To collaborate with stakeholders to define project scope, objectives, deliverables and accordingly prepare and submit status reports for minimizing exposure and closure of escalations.