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Norgine
Norgine
1.001 – 5.000 Angajați
Sponsor pentru viza de lucrător calificatAsistență medicalăIndustria prelucrătoareProduse farmaceutice
Norgine este o companie farmaceutică europeană specializată, cu o istorie care datează din 1906. Echipa sa achiziționează, dezvoltă și comercializează medicamente printr-o rețea globală de parteneriate, având o expertiză deosebită în gastroenterologie și hepatologie. Produsele companiei ajung anual la aproximativ 25 de milioane de pacienți din întreaga lume, cu sprijinul a peste 1.400 de angajați și al unor vânzări nete de produse de peste 500 de milioane de euro. Norgine colaborează cu partenerii prin acorduri de licențiere, achiziții și entități cu scop special, reinvestind în același timp în dezvoltarea medicamentelor viitoare.
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Computer Systems Validation Engineer (12-Month Contract) at Norgine

Support validation of Norgine’s regulated computer systems, helping maintain GxP compliance and data integrity. Apply risk-based validation practices across systems and their lifecycle.

GBRegatul UnitHibridContractNivel mediuSeniorLimbă Obligatorie: englezăInginer
ERP

Descriere

  • Plan and deliver validation for new and existing GxP-regulated computerised systems.
  • Prepare and maintain validation plans, risk assessments, protocols, test scripts, reports and traceability matrices.
  • Test and verify systems against business, quality and regulatory requirements.
  • Provide validation evidence for audits, inspections and regulatory enquiries.
  • Partner with Quality, Manufacturing, Engineering, IT and vendors to assess changes and incorporate validation throughout the system lifecycle.
  • Improve validation standards, processes and practices.
  • Help maintain compliance of Norgine’s regulated systems, equipment, validation records and related processes with applicable quality and regulatory requirements.
  • Provide lifecycle validation expertise and use risk-based methods to support compliance, data integrity and operational effectiveness.

Cerințe

  • Bachelor’s degree or equivalent qualification or experience in computer systems, engineering or a related field.
  • Experience using relevant procedures or systems.
  • Skills in quality assurance methods, review and reporting, data collection and analysis, planning, requirements verification and project quality management.
  • Ability to interpret complex information, make sound decisions and determine appropriate actions.
  • Strong communication and teamwork skills, including confidence to raise compliance concerns when needed.
  • A structured and accountable approach to documentation, testing and delivery.
  • Working knowledge of GxP and data integrity principles, including GAMP 5, EU GMP Annex 11 and 21 CFR Part 11 guidance.
  • Experience preparing and executing validation documents such as risk assessments, protocols, test scripts and validation reports.
  • Familiarity with regulated computerised systems in manufacturing, laboratories, quality, ERP, MES or LIMS.

Beneficii

  • Ongoing professional development in a supportive, inclusive workplace.
  • Career development opportunities.
  • Work that contributes to improving patients’ lives.
  • Benefits vary by location; ask the Norgine Talent Acquisition representative for details.