margit__eriksson_cv_03-2016 english
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CV – Margit Eriksson
Mail: [email protected]: 1960
Danshøjvej 36, st2500 Valby
Danmark
ErhvervserfaringPharmaceutical Affairs Manager november 2014 – januar 2016Stragen Nordic A/S
GDP responsible towards DHMA for distribution of medicinal products in Nordic countries, Local PV, responsible for medical information questions.
Head of QA, Qualified Person, supervisor for GDP i BI-Norden
august 2013 – oktober 2014
Boehringer Ingelheim Danmark A/S
Responsible manager for a team of 5 persons.Release of sterile and non-sterile veterinary medicinal products.Quality Assurance of medicinal products under GMP and GDP and the food ministry self-control program (ISO9001 + HACCP).Quality Assurance - handling of change control requests, deviations and complaints, CAPA, self-inspection, auditing of outsourced activities, contracts, receipt of authority inspections, secondary re-packaging of medicinal products, PQR and Quality Management Review, Quality Manual, document management and training.
QA Manager (extended business trip to BI head office in Germany)
februar 2013 – juli 2013
Stationed in Head Quarter in Boehringer Ingelheim Germany in Corporate QA in the Third Party Quality Management Group
Creating a template for a Quality Manual for a daughter sales company of BI holding a Wholesaler License.Updating the corporate procedure for PQR/APR to include new legislation for EU/FDA for finished products and active substances.
Head of QA, Qualified Person,Supervisor for GDP i BI-Norden (regional quality and complaince officer)
juli 2010 – januar 2013
Boehringer Ingelheim Danmark A/S
Margit Eriksson, Danshøjvej 36, st , 2500 Valby 1 15. januar 2016
Responsible manager for a team of 3 persons.Release of sterile and non-sterile veterinary medicinal products.Quality Assurance of medicinal products under GMP and GDP and the food ministry self-control program (ISO9001 + HACCP).Quality Assurance - handling of change control requests, deviations and complaints, CAPA, self-inspection, auditing of outsourced activities, contracts, receipt of authority inspections, secondary re-packaging of medicinal products, PQR and Quality Management Review, Quality Manual, document management and training.
Head of QA, Qualified Person maj 2005 – juni 2010Boehringer Ingelheim Danmark A/S
Responsible manager for a team of 2 persons.Release of sterile and non-sterile veterinary medicinal products.Quality Assurance of medicinal products under GMP and GDP and the food ministry self-control program (ISO9001 + HACCP).Quality Assurance - handling of change control requests, deviations and complaints, CAPA, self-inspection, auditing of outsourced activities, contracts, receipt of authority inspections, secondary re-packaging of medicinal products, PQR and Quality Management Review, Quality Manual, document management and training.
RA and Quality Assurance Officer januar 2004 – april 2005Boehringer Ingelheim Danmark A/S
Batch record review and preparation for release of sterile and non-sterile medicinal products Quality Assurance of medicinal products under GMP and GDP and the food ministry self-control program (ISO9001 + HACCP).Quality Assurance - handling of change control requests, deviations and complaints, CAPA, self-inspection, auditing of outsourced activities, contracts, receipt of authority inspections, secondary re-packaging of medicinal products, PQR and Quality Management Review, Quality Manual, document management and training.
(3 days a week)
Maintenance of regulatory files for the veterinary medicinal products in the Nordic area owned by the company. (2 days a week)
RA and Quality Assurance Officer februar 1996 – december 2003Ferring Pharmaceuticals A/S
Margit Eriksson, Danshøjvej 36, st , 2500 Valby 2 15. januar 2016
Regulatory affairs of in-licensed products for DK market.Release of medicinal products, Quality Assurance - handling of change control requests, deviations and complaints, self-inspection, auditing of outsourced activities
1995-06-01 Janssen-Cilag A/S Temporary job (maternity leave)Manager of Regulatory Affairs
1994-12-01 Novo Nordisk A/S Chemist in R&D pilot plant sterile production
1994-04-01 State Serum Institute, Denmark
Pharmacist in the Vaccine Production dep.
1992-04-01 Maternity leave 6 months
1991-04-01 Central Hospital in Nykøbing F, Denmark.
Temporary job (maternity leave)Manager of the Medicinal distribution
1990-10-01 Maternity leave 6 months
1990-07-01 M.Sc.Pharm.
1988-1989 Frederiksberg Hospital
Part time assistant in the Sterile Production
EducationM.Sc.Pharm. september 1980 – juni 1990The Royal Danish School of Pharmacy
Competencies Departmental management, operation Pharmaceutical work Quality Assurance Sterile production
Drivers license B – Ordinary car Willing to use own var in the job
Language Dansk – Fluent Engelsk – Fluent Fransk – Basic
Svensk – Good Tysk – Good
Margit Eriksson, Danshøjvej 36, st , 2500 Valby 3 15. januar 2016
ProfilQualified Person, Can act a s a qualified person for release of medicinal products
Name: Margit Eriksson
Address: Danshøjvej 36, 2500 Valby
Phone: +45 40568088
e-mail: [email protected]
Birthday: 1960-07-19
Civil status: Married in 1990, Divorced in 1999 after 20 years together
Children: 2 boys, 23 and 25 years’ old
Hobbies: Salsa dance, Cooking, Book reading, Running, Skiing, Outdoor life
Margit Eriksson, Danshøjvej 36, st , 2500 Valby 4 15. januar 2016