Profil #10454

Motivated and committed M.Sc. in Biomedicine I am a very positive and energetic person which thrives in an informal and dynamic environment. I have a solid background in clinical communication, GMP/GDP documentation, drug safety issues, supply chain structures and national compliance.
drug sagety QA kvalitet GMP  
Opdateret 24. september 2019
Min uddannelse
2000 - 2006

Cand.scient. i Medicinalbiologi

Syddansk Universitet (SDU)

Uddannelsesområde: Medicinal & Sundhed
Periode: september 2000 - december 2006
Min erhvervserfaring
2016 - nu

QA specialist

Virksomhedsnavn skjult

Review and approval of quality documentation Responsible for GDP assignments and supply chain issues Handling and reporting of complaints Planning and performing internal audits and external supplier audits Supplier qualification Planning and hosting inspections Management of company authorisations Review and approval of CAPAs and deviations Writing and maintaining SOPs Participation in projects
Arbejdsområde: Medicinal & Sundhed
Periode: september 2016 - nu
2007 - 2016

Akademisk medarbejder

Virksomhedsnavn skjult

Handling of product defects and recalls of medicinal products Communication and troubleshooting with pharmaceutical companies and wholesalers Cowork with National Authorities Issuing of European alerts and evaluation of safety data Authorisation of pharmaceutical companies (§39) Setting up and maintaining a report system for adverse reactions within cell and tissue banks in Denmark.
Arbejdsområde: Medicinal & Sundhed
Periode: september 2007 - september 2016
Mine kompetencer
Evner
audits compliance dokumentation drug safety gmp pharmacovigilance qa
Sprog på arbejdsniveau
ingen angivet
Mine præferencer
Jobtype
alle
Arbejdsområde
Medicinal & Sundhed
Geografi
Nordsjælland Storkøbenhavn
Kontakt mig!