Jobs
>
Cary

    CSV Technical Lead - Raleigh, United States - Katalyst Healthcares & Life Sciences

    Katalyst Healthcares & Life Sciences
    Katalyst Healthcares & Life Sciences Raleigh, United States

    1 week ago

    Default job background
    Description
    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 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 a 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.
  • Centraprise

    Technical Lead

    2 weeks ago

    Centraprise Cary, United States

    Role: EAutomate technical lead · Location: Cary, NC · Mode: Fulltime · JD: · Technical/Functional Skills · 1. Proven experience as an eAutomate Technical Lead or similar role, with a minimum of 5 years of hands-on experience. · 2. Deep understanding of eAutomate architecture, mo ...

  • Tata Consultancy Services

    Technical Lead

    3 weeks 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 ...

  • US Main

    Technical lead

    3 weeks 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 ...

  • ApTask

    eAutomate Technical Lead

    1 week ago

    ApTask Cary, United States

    Position: eAutomate Technical Lead · Location: Cary, NC (Onsite) · Duration: Fulltime · Job Description: · Proven experience as an eAutomate Technical Lead or similar role, with a minimum of 5 years of hands-on experience. · Deep understanding of eAutomate architecture, modules, ...

  • eTeam

    Salesforce Technical Lead

    1 week ago

    eTeam Cary, United States

    Job Description: · 5 to 9 years of development experience, with a strong focus on LWC, Apex and Visual force development · Hands on experience on understanding of CRM. · Hands on LWCs, LDS components and Aura framework development. · Lead a team of Client developers, provide so ...

  • Katalyst HealthCares & Life Sciences

    CSV Technical Lead

    3 weeks 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 ...

  • HCL Technologies

    lead technical consultant

    4 days ago

    HCL Technologies Cary, United States

    Job Description (Posting). · To create, assign and track the project [module] work plans for delivery and also provide technical guidance for work completion. (1.) To ensure process improvement and compliance in the assigned module, and participate in technical discussionsorrevi ...

  • Epic Games

    Lead Technical Designer In Animation

    1 day ago

    Epic Games Cary, United States

    ART · What We Do · Push your creative talents to the limit on a team of world-class artists, designers, and engineers who strive to innovate and inspire. · What You'll Do · Epic Games is looking for a Lead Technical Designer in Animation (TDiA) to join our team working across var ...

  • TEPHRA

    ServiceNow FSM Technical Lead

    1 week ago

    TEPHRA Cary, United States

    : · ServiceNow Field Service Management (FSM) Technical Lead · Technical Lead will need to have experience leading teams in an Agile approach, leading solution design sessions, and ensuring quality of delivery of the ServiceNow solution. · Responsibilities: Work with the custom ...

  • MetLife

    Senior Salesforce Technical Lead

    4 days ago

    MetLife Cary, United States

    Senior Salesforce Technical Lead · Location(s) · Posting Location:Cary, North Carolina · Country · United States · Working Schedule · Full-Time · Work Arrangement · Hybrid · Relocation Assistance Available · No · Posted Date · 13-May-2024 · Job ID · 2543 · Description and Require ...

  • MetLife

    Senior Salesforce Technical Lead

    5 days ago

    MetLife Cary, United States

    MetLife · Senior Salesforce Technical Lead · Cary , · North Carolina · Apply Now · This technical leadership role helps us deliver advanced Salesforce solutions for our business by designing and engineering solutions to address business opportunities and then providing overs ...

  • Garmin

    Technical Lead Software Engineer

    3 weeks 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 ...

  • MetLife

    Lead Technical Functional Analyst

    5 days ago

    MetLife Cary, United States

    Lead Technical Functional Analyst · Location(s) · Posting Location:Cary, North Carolina · Country · United States · Working Schedule · Full-Time · Work Arrangement · Hybrid · Relocation Assistance Available · No · Posted Date · 23-Feb-2024 · Job ID · 1553 · Descrip ...

  • LVI Associates

    Technical Controls Engineer Lead

    5 days ago

    LVI Associates Cary, United States

    I am working with an AEC (Architecture, Engineering & Construction) firm who is a dynamic and innovative company specializing in Food & Beverage and Packaging Industries. Committed to pushing the boundaries of technology and delivering cutting-edge solutions to there clients. · J ...

  • Tata Consultancy Services

    ServiceNow CSM Technical Lead

    1 week ago

    Tata Consultancy Services Cary, United States

    ServiceNow Customer Service Management (CSM) Technical Lead Technical Lead will need to have experience leading teams in an Agile approach, leading solution design sessions, and ensuring quality of delivery of the ServiceNow solution. Responsibilities: Work with the customer pro ...

  • LVI Associates

    Technical Controls Engineer Lead

    5 days ago

    LVI Associates Cary, United States

    I am working with an AEC (Architecture, Engineering & Construction) firm who is a dynamic and innovative company specializing in Food & Beverage and Packaging Industries. Committed to pushing the boundaries of technology and delivering cutting-edge solutions to there clients. · ...

  • Epic Games

    Lead Technical Designer in Animation

    6 days ago

    Epic Games Cary, United States

    WHAT MAKES US EPIC? · At the core of Epic's success are talented, passionate people. Epic prides itself on creating a collaborative, welcoming, and creative environment. Whether it's building award-winning games or crafting engine technology that enables others to make visually s ...

  • MetLife

    Senior Salesforce Technical Lead

    2 weeks ago

    MetLife Cary, United States Full time

    Description and Requirements · Role Value Proposition: · This technical leadership role helps us deliver advanced Salesforce solutions for our business by designing and engineering solutions to address business opportunities and then providing oversight of a variety of first-tie ...

  • Epic Games

    Lead Technical Designer in Animation

    6 days ago

    Epic Games Cary, United States

    WHAT MAKES US EPIC? · At the core of Epic's success are talented, passionate people. Epic prides itself on creating a collaborative, welcoming, and creative environment. Whether it's building award-winning games or crafting engine technology that enables others to make visually s ...

  • Tekfortune Inc

    Technical Lead

    2 weeks 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 ...