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Norgine
Norgine
1001 – 5000 Darbinieki
Kvalificēta darbinieka vīzas sponsorsFarmaceitiskie produktiRažošanaVeselības aprūpe
Norgine ir Eiropas specializēts farmācijas uzņēmums, kura vēsture aizsākās 1906. gadā. Tā komanda iegādājas, izstrādā un komercializē zāles, izmantojot globālu partnerību tīklu, un uzņēmumam ir īpaša pieredze gastroenteroloģijā un hepatoloģijā. Uzņēmuma produkti ik gadu sasniedz aptuveni 25 miljonus pacientu visā pasaulē. Uzņēmuma darbību atbalsta vairāk nekā 1 400 darbinieku un neto produktu pārdošanas apjoms, kas pārsniedz 500 miljonus eiro. Norgine sadarbojas ar partneriem licencēšanas, iegāžu un īpašam nolūkam izveidotu uzņēmumu jomā, kā arī atkārtoti iegulda nākotnes zāļu izstrādē.
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Vakances uzņēmumā

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.

GBApvienotā KaralisteHibrīdiLīgumsVidējais līmenisVecākais speciālistsNepieciešamā Valoda: angļuInženieris
ERP

Apraksts

  • 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.

Prasības

  • 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.

Priekšrocības

  • 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.