Jobs
>
Cary

    CSV Technical Lead - Cary, United States - Katalyst HealthCares & Life Sciences

    Katalyst HealthCares & Life Sciences
    Katalyst HealthCares & 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

    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.

    #J-18808-Ljbffr
  • Centraprise

    Technical Lead

    3 days 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

    2 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 ...

  • 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

    2 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 ...

  • 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 ...

  • ApTask

    eAutomate Technical Lead

    1 day 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

    4 hours 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 and Life Sciences

    CSV Technical Lead

    2 weeks ago

    Katalyst Healthcares and 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 implementa ...

  • Garmin

    Technical Lead Software Engineer

    2 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 ...

  • 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 ...

  • MetLife

    Senior Salesforce Technical Lead

    3 days 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 ...

  • GFL Environmental

    Technical Lead

    2 weeks 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 ...

  • Katalyst Healthcares and Life Sciences

    Technical Lead

    1 week 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 ...

  • Quantam Solutions

    Technical Lead

    3 hours ago

    Quantam Solutions Raleigh, 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 Technical Specialist-Expert (Technical Lead) for the Department of Transportati ...

  • Bayforce

    Technical Lead

    2 weeks 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 ...

  • 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 ...

  • GFL Environmental

    Technical Lead

    2 weeks 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 ...

  • 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 ...

  • First Citizens Bank

    Technical Lead

    4 days 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

    2 weeks 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 ...