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