Alvotech hf
Alvotech hf
Alvotech hf

DPM Documentation Coordinator

Responsible for continuous professional development to maintain up-to-date knowledge of new regulatory requirements and technical developments relevant to own area of expertise. Proactively share knowledge for the benefit of others. Ensure all training assignments are completed within the given due date. Responsible for supporting operations and providing expertise in documentation and quality records in DPM.

Menntunar- og hæfniskröfur
Education: BSc or Diploma in a Technical Discipline (e.g., pharmacy, biotechnology, biochemistry, engineering, or a related field). Experience: Minimum of 2 years experience working in a GMP environment. Skills: Excellent written and verbal communication skills. Proficient in the use of a PC and common Microsoft packages such as Word, Visio, and Excel. Biopharma experience is advantageous. Must hold EU working visa Experience in quality document management advantageous, e.g., Veeva Quality System, FirstDocs, Trackwise
Helstu verkefni og ábyrgð
Oversee MBRs status in DPM, including changes, updates, and continuous improvements in coordination with the DPM Manager, Team leaders, and MSAT. Be an SME author/reviewer of MBRs. Support DPM Teams with reviewing executed BRs as required. Be an SME author/reviewer and/or approver for written procedures, SOPs, etc. Be an SME author/reviewer of deviations, CAPAs, and investigations relating to DPM processes as required in the span of expertise.
Auglýsing birt19. september 2022
UmsóknarfresturEnginn
Tungumálahæfni
EnskaEnska
Nauðsyn
Meðalhæfni
Staðsetning
Sæmundargata 15-19 15R, 101 Reykjavík
Starfstegund
Starfsgreinar
Starfsmerkingar