CSV Senior Specialist for GMDC

CSV Senior Specialist for GMDC

Extelligence is an intelligent partner that goes the extra mile. We provide customized information management solutions for major industries. Our team in Prague and Bucharest is working with international companies, transforming, and adding value to their business on a daily basis. We are growing quickly, and we are interested to bring more talented individuals into our team.

 Position overview:

  • Computer Systems Validation (CSV) Senior Specialist will be responsible for the validation of Global Manual Data Capture (GMDC) computerized system to ensure compliance with company policies, procedures and regulatory expectations. GMDC is a GMP validated custom build system for digitalization of MMD manual data to enable their usage for analytical purposes. The scope of the GMDC includes evolution and adoption of the application to meet business and regulatory requirements.
  • GMDC Product Team operates withing Agile/Scrum methodology, CSV Senior Specialist will be part of the Scrum team and collaborate with Product owner. GMDC is part of the Mantis Application Enablement product, hence CSV Senior Specialist will tightly collaborate on the Mantis Application Enablement Product as well
  • CSV Senior Specialist for GMDC will work closely with stakeholders and subject matter experts from technical, testing, business and quality teams, IT risk assessment and data privacy offices, to ensure all validation activities are completed throughout the computer system lifecycle and facilitate continuous improvement.

Role description:

  • Author, implement and maintain computerized system’s state of validation and compliance throughout its SDLC
  • Suggest process improvements or industry standards which could be applied to improve efficiency and compliance adherence
  • Author/review of CSV deliverables such as Validation Plan, Requirements Specification, Test Plan, Summary Reports, Requirements Traceability, Operating procedures (SOPs)
  • Oversee of delivery timelines for SDLC documents for respective product release
  • Administer SDLC deliverables and trainings for SOPs in official repositories
  • Author and manage change control in official system
  • Support configuration management (define IT asset strategy for new products)
  • Support assessments (IT risk assessment, Data privacy, Supplier assessment)
  • Support incident and deviation management (requestor/author/contributor)
  • Support periodic review process
  • Support regulatory inspection and audit activities as needed
  • Build compliance knowledge within product team
  • Communicate with other stakeholders and team members around ideas and findings relevant for the overall platform
  • Operate as part of a self-directed team in carrying out day to day functions and assigning priorities

Skills & Experience:

  • The ideal candidate shall have 5+ years working in computer system validation, preferably in a pharmaceutical environment
  • Clear understanding of principles, procedures, governance of validation activities in IT controls and system development life cycle
  • Preferred to have knowledge of validation of GxP computerized systems within FDA regulated environments with a strong understanding of industry standards and best practices for computer validation such as GAMP 5, 21 CFR Part 11, and applicable predicate regulations
  • Ability to think critically and demonstrate risk based approach to validation strategy
  • Analytical problem solving skills applied to issue identification and resolution
  • Demonstrated ability to establish and maintain collaborative relationships with stakeholders
  • Computer system validation, agile software methodology and lean process experience
  • Good documentation practice for GMP preferred
  • Knowledge of MS Office applications, MS Teams, JIRA and Confluence preferred

Working with Extelligence:

  • We take care of the important things that matter to contractors, for example, we guarantee on-time payment for your work. You will never have to chase us for payment.
  • We always seek to have long term relationships with our team and we always seek to offer opportunities to extend cooperation beyond the first contract or project.
  • Extelligence is a multicultural team, we have more than 15 different nationalities working with us.
  • We also organize events to bring our team together including team building activities and social events.
Job Type: Contract
Job Location: Czech Republic Hybrid Prague

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