HCL Technologies
SOLUTION ARCHITECT
Job Location
Five Corners, NJ, United States
Job Description
Job Description (Posting).
New Billing, Exclusive, CommittedPS- Computer System Validation and IT ComplianceSS- Validating Clinical systems and or clinical supplies and or Safety and or Manufacturing systems, IT Compliance, Periodic Review, CAPA ManagementJD- 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 - Clinical Development and Supply Chain, Drug Discovery, MES, QMS, LIMS, Data Integrity PlatformsGuide 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.Performs Periodic ReviewPerforms CAPA Management, Deviations Management
Location: Five Corners, NJ, US
Posted Date: 11/30/2024
New Billing, Exclusive, CommittedPS- Computer System Validation and IT ComplianceSS- Validating Clinical systems and or clinical supplies and or Safety and or Manufacturing systems, IT Compliance, Periodic Review, CAPA ManagementJD- 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 - Clinical Development and Supply Chain, Drug Discovery, MES, QMS, LIMS, Data Integrity PlatformsGuide 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.Performs Periodic ReviewPerforms CAPA Management, Deviations Management
Location: Five Corners, NJ, US
Posted Date: 11/30/2024
Contact Information
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