Jobs
>
Cary

    CSV Technical Lead - Cary, United States - Katalyst Healthcares and Life Sciences

    Katalyst Healthcares and Life Sciences
    Katalyst Healthcares and Life Sciences Cary, United States

    2 weeks ago

    Default job background
    Description
    Responsibilities:
    • 10 + years Experience in Validating GxP applications
    • Experience in FDA and/or Global regulated environment with good understanding of GCP , GLP and Risk based validation strategy
    • Provides consultation and counseling on Risk and Compliance module implementation in reference to regulatory quality
    • Support Risk assessment
    • Document Regulatory Requirements and Review Specification documentation (viz. User Stories, URS, FRS)
    • Review and final Approval of requirements, Technical Design and Solution Architecture Plan, IQ, OQ and PQ pre and post execution documents
    • Lead, Write, Review/ Approve Discrepancy Logs (final dispositions)
    • Lead, Write, Review / Approve Requirement Traceability Matrix (RTM) and Validation Summary Reports
    • Good to Have (secondary skills)
    • Experience in Clinical systems like CTMS, CDMS, EDC, Veeva Vault, QMS and Safety Systems and Infrastructure Qualification
    • Conduct Periodic Reviews of GxP Apps as per the frequency stated in the governing SOP and write Periodic review reports and Review and Approve Periodic Review Reports.
    Requirements:
    • Tracks the Periodic review findings and open CAPA s to a closure.
    • Review and Approve System Support and Operations plan.
    • Participate in and support Audits.
    • Contribute and Review/ Approve Decommissioning Plans & Decommissioning Reports.
    • Contribute, Review/ Approve deliverables for Change Management Support.
    • Maintain validation documentation throughout product lifecycle result of Change, Periodic Review, Audits.
    • Immaculate communication and handles multiple clients/ projects
    • Works in Consulting capacity.
    • To ensure process improvement and compliance, and participate in technical design discussion and to review technical documents.
    • Co-ordination with On-Site Engineers and attending customer calls.
    • Raising risks, issues and escalation to senior management and customer.
    • To create all quality documents, collect metrics data and conducting Audits. To perform Value creation and KM activities.
    • To create project plans and keep track of schedule for on time delivery as per the defined quality standards.
  • Tata Consultancy Services

    Technical Lead

    1 week ago

    Tata Consultancy Services Cary, United States

    Role: .NET Full Stack Lead/Developer · •Experience in software development with strong technical understanding of designing and building enterprise scale web-based application in the Cloud. · •Expertise in front-end languages such as HTML, CSS, and JavaScript. · •Experience wo ...

  • HCL Technologies

    Technical Lead

    2 weeks ago

    HCL Technologies Cary, United States

    Job Description (Posting). · Attrition/Committed /Exclusive " 9+ years of hands-on programming experience using Java development with Spring Framework / Apache Camel Framework Strong experience in building and designing RESTful APIs 8+ yrs of experience developing microservices ...

  • US Main

    Technical lead

    1 week ago

    US Main Morrisville, United States

    Responsibilities · Creation of software architecture and requirements. · Generation of regression test plans for validation. · GUI development including working with customers and outside agencies. · Software process development including interfacing with peripheral devices, secu ...

  • Katalyst Healthcares & Life Sciences

    CSV Technical Lead

    1 week ago

    Katalyst Healthcares & Life Sciences Raleigh, United States

    Responsibilities: years Experience in Validating GxP applications · Experience in FDA and/or Global regulated environment with good understanding of GCP , GLP and Risk based validation strategy · Provides consultation and counseling on Risk and Compliance module implementa ...

  • Katalyst HealthCares & Life Sciences

    CSV Technical Lead

    1 week ago

    Katalyst HealthCares & Life Sciences Cary, United States

    Responsibilities: · 10 + years · Experience in Validating GxP applications · Experience in FDA and/or Global regulated environment with good understanding of GCP , GLP and Risk based validation strategy · Provides consultation and counseling on Risk and Compliance module impl ...

  • Garmin

    Technical Lead Software Engineer

    1 week ago

    Garmin Cary, United States

    Overview · We are seeking a full-time · Technical Lead Software Engineer · on our Networking Technology team in our Cary, NC location. (this is an individual contributor role). · As a member of the Networking Technology team, you will deliver software features for a diverse s ...

  • Garmin International Inc

    Technical Lead Software Engineer

    2 weeks ago

    Garmin International Inc Cary, United States

    Overview · We are seeking a full-time Technical Lead Software Engineer on our Networking Technology team in our Cary, NC location. (this is an individual contributor role). As a member of the Networking Technology team, you will deliver software features for a diverse set of inn ...

  • Tekfortune Inc

    Technical Lead

    3 days ago

    Tekfortune Inc Raleigh, United States

    Tekfortune is a fast-growing consulting firm specialized in permanent, contract & project-based staffing services for world's leading organizations in a broad range of industries. In this quickly changing economic landscape, virtual recruiting and remote work are critical for the ...

  • GFL Environmental

    Technical Lead

    1 week ago

    GFL Environmental Raleigh, NC, United States

    Under general direction of the Branch Technologies Department Manager, the Technical Lead will oversee the technical aspects of deploying and maintaining our branch software and technologies by participating in architectural and design decisions, guiding other IT teams' members i ...

  • First Citizens Bank

    Technical Lead

    5 hours ago

    First Citizens Bank Raleigh, United States

    OverviewThis position provides specialized technical leadership during the architecture, design, implementation, and support of assigned systems and applications. Primary application focus will be on a new implementation of Icertis Contract Lifecycle Management (CLM). Directs dec ...

  • GFL Environmental

    Technical Lead

    1 week ago

    GFL Environmental Raleigh, United States

    Under general direction of the Branch Technologies Department Manager, the Technical Lead will oversee the technical aspects of deploying and maintaining our branch software and technologies by participating in architectural and design decisions, guiding other IT teams' members i ...

  • Bayforce

    Technical Lead

    1 week ago

    Bayforce Raleigh, United States

    A client in the manufacturing industry is looking for a Technical Lead to join their innovative Salesforce team. In this role, you will be responsible for designing, developing, and integrating solutions on This person will be responsible for leading the design and implementatio ...

  • GFL Environmental

    Technical Lead

    1 week ago

    GFL Environmental Raleigh, NC, United States

    Under general direction of the Branch Technologies Department Manager, the Technical Lead will oversee the technical aspects of deploying and maintaining our branch software and technologies by participating in architectural and design decisions, guiding other IT teams' members i ...

  • Quantam Solutions

    Technical Lead

    1 week ago

    Quantam Solutions Raleigh, NC, United States

    Quantam Solutions provides IT solutions and consulting for the State of North Carolina. We offer a competitive hourly wage, health benefits, paid time off, and a 401(k) plan. We're currently seeking a Specialist-Expert (Technical Lead) for the Department of Transportation. · JOB ...

  • Katalyst Healthcares and Life Sciences

    Technical Lead

    3 days ago

    Katalyst Healthcares and Life Sciences Raleigh, United States

    Responsibilities: looking for a pure validation resource with periodic review, audit experience. · We are 10 + years Experience in Validating GxP applications. · Experience in FDA and/or Global regulated environment with good understanding of GCP , GLP and Risk based validation s ...

  • eTeam

    Onbase/Docushare Application Technical Lead

    5 hours ago

    eTeam Cary, United States

    1.Docushare/Onbase development and Administration including Creation and Configuration of Keyword Type, Document Type, User, User Group, Auto-Fill keyword set, DIP, Scan Queues, Capture, Workflow, Work view, Unity Script and VB Script. · 2. Docushare Migration old to new / target ...

  • Tekfortune Inc

    Technical Lead

    1 week ago

    Tekfortune Inc Raleigh, United States

    Tekfortune is a fast-growing consulting firm specialized in permanent, contract & project-based staffing services for world s leading organizations in a broad range of industries. In this quickly changing economic landscape, virtual recruiting and remote work are critical for the ...

  • Bayforce

    Technical Lead

    1 week ago

    Bayforce Raleigh, United States

    A client in the manufacturing industry is looking for a Technical Lead to join their innovative Salesforce team. In this role, you will be responsible for designing, developing, and integrating solutions on This person will be responsible for leading the design and implementatio ...

  • eTeam

    Java Full Stack Senior Technical Lead

    1 week ago

    eTeam Cary, United States

    Java, Spring, UI, SQL Looking for full stack Java developers 1.12+ years of experience 2.Will be extremely hands on with design, development, unit test, build/deploy, operational support 3.Demonstrated experience in OOAD using established methodologies and notations such as UML a ...

  • eTeam

    Senior Application Analyst/Senior Technical Team lead

    2 days ago

    eTeam Cary, United States

    Job Title/Role Senior Application Analyst/Senior Technical Team lead Experience Level Required in Years 8-10 Years Mandatory Required Skills Java8, Springboot, Angular, React, Postgres Database, IBM DB2 , REST, GraphQL, Cloud ( AWS ) , Microservices based business applications. P ...