Alvotech hf
Alvotech hf
Alvotech hf

F&F MSAT Senior Specialist

Lead the Transport validation activities for the Drug Substance, Drug product and Finished product presentations. Addressing the regulatory queries and dossier review for TV projects.

Helstu verkefni og ábyrgð
  • Responsible for leading the Transport validation activities for the Drug Substance, Drug product and Finished product presentations.
  • Be an SME author/reviewer and/or approver for written procedures, SOPs, protocols, sample plan and reports etc. related to Transport Validation.
  • Responsible for performing process risk assessments. Be an SME author for performing risk assessments relating to transport validation processes.
  • To be a key team member contributing to successful commercial Pre-Approval Inspections (PAIs), regular Audits and any other interaction with regulatory agencies as required.
  • Responsible for addressing the regulatory queries and dossier review for transport validation sections.
  • Be a single point of contact (SPC) for Transport validation responsibilities.
  • Be an SME author of Deviations, CAPAs and change controls.
Menntunar- og hæfniskröfur
  • Education: MSc in Pharmaceutical Biotechnology or other applicable field of study.
  • Experience: 10-15 Years in the field of Biopharmaceutical Industry.
Fríðindi í starfi
  • An inspiring challenge to work with great co-workers on ambitious projects that change people's lives.
  • The chance to be a part of a global and fast-growing company.
  • An international work culture that encourages diversity, collaboration and inclusion.
  • Positive, flexible, and innovative work environment.
  • Support for personal growth and internal career development.
  • Company social events and milestone celebrations.
  • Excellent in-house canteen and coffee house.
  • Exercise and wellbeing support for full-time employees.
  • On-site shower facility.
  • Transportation grant towards eco-friendly modes of travel for full-time employees.
  • Internet at home for full-time employees.
Auglýsing birt30. október 2024
Umsóknarfrestur17. nóvember 2024
Tungumálahæfni
EnskaEnska
Nauðsyn
Framúrskarandi
Staðsetning
Sæmundargata 15-19 15R, 101 Reykjavík
Starfstegund
Starfsgreinar
Starfsmerkingar