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Deloitte
Deloitte
Sponsor pentru viza H1BConsultanțăConsultanță financiarăTehnologie, media și telecomunicații
Deloitte este o companie globală de servicii profesionale care activează în domeniile consultanței, consultanței financiare și tehnologiei, mass-mediei și telecomunicațiilor. Activitatea sa include servicii de audit, fiscalitate, consultanță și consiliere, care ajută organizațiile să abordeze provocări de afaceri complexe, să își transforme operațiunile și să ia decizii bine fundamentate. Profilul companiei evidențiază, de asemenea, inovația, practicile sustenabile, incluziunea, diversitatea și colaborarea ca elemente importante ale mediului său de lucru.
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Computer Systems Validation Consultant

Support Deloitte’s Life Sciences and Healthcare clients with compliant computerised systems validation. Deliver risk assessments, CAPA support, regulatory compliance guidance, and inspection-readiness activities across regulated environments.

IEIrlanda
45.000 € / an
HibridNormă întreagăNivel mediuSeniorLimbă Obligatorie: englezăConsultant
SDLCVault

Descriere

  • Prepare, execute, and review computerised systems validation deliverables against FDA, EMA, ICH, and other applicable regulations.
  • Advise clients on computer systems validation practices and regulatory compliance.
  • Complete validation activities in line with client requirements.
  • Apply risk-based approaches and identify opportunities to improve processes.
  • Guide project teams in correcting validation documentation and resolving test defects.
  • Monitor systems and processes for adherence to SOPs, audit requirements, and industry best practices.
  • Manage validation change-control documentation and support CAPA and quality metrics programmes.
  • Assess system impact and classify validation requirements using risk-based validation principles.
  • Support adherence to GAMP 5 and data integrity expectations.
  • Lead inspection-readiness work, including gap assessments, mock audits, validation package reviews, and regulatory inspection responses.
  • Collaborate with Deloitte Audit and Assurance teams and Life Sciences and Healthcare clients.

Cerințe

  • Degree in Software, IT, Pharma, Science, or a related discipline.
  • Demonstrated experience in an IT-related field.
  • Experience with JIRA, TrackWise, or Veeva Vault.
  • Experience validating computerised systems with AI integration is preferred but not required.
  • Experience in regulated industries is preferred.
  • Understanding of EudraLex Volume 4, including Annex 11.
  • Understanding of FDA 21 CFR Part 11 and Good Automation Practices (GAMP).
  • Understanding of SDLC and Agile and Waterfall methodologies.
  • Basic knowledge of quality management systems and data integrity principles.
  • Experience managing CAPA lifecycle activities.
  • Experience supporting inspection readiness for FDA or EMA audits.
  • Experience applying 21 CFR Part 11, EU Annex 11, GAMP 5, and ALCOA+ principles.
  • Proficiency with Microsoft Office tools.

Beneficii

  • Health and wellbeing support.
  • Pension and savings options.
  • Training and coaching.
  • Enhanced leave options.
  • Flexible hybrid working combining office and remote work.

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