пропозиції роботи
Marta Banaszczyk-Ruś
właściciel, PharmConsult
Wiązowna,
mazowieckie
Dołącz do GoldenLine i obejrzyj pełny profil tej użytkowniczki
Zobacz pełny profil
Języki
angielski
dobry
Doświadczenie zawodowe
owner
PharmConsult (earlier MBR-Doradztwo Farmaceutyczne i inne)
Cooperation with pharmaceutical companies in the field of preparation of the documentation for drug products: preparation of documentation for variations and new products -Module 1 (administrative documents), 2 (summaries) and 3 (documentation) in CTD format for MRP, DCP and national procedures.
Regulatory Affairs Specialist
Preparation of documentation for variations and new products in the MRP, DCP and national procedures. Assessment of administartive and chemical, pharmaceutical and biological documentation. Submittion application for paralel import.
Specialist for microbiological control of pharmaceutical products
National Institute of Public Health
Antibiotics and Microbiology Department - testing (biological and chemical analysis) of medicinal products according to European requirements; assessment of chemical, biological and pharmaceutical documentation for medicinal products – documentation for new products, variations and harmonisation (documentation submitted by pharmaceutical companies to Office for Registration of Medicinal Products, Medical Devices and Biocidal Products)
Junior specialist for registration of medicinal products
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Unit for Natural Origin, Homeopathic and Galenical Products - organization and coordination of the process: licensing for trade, renewals and variations for the products registered in national procedures; validation of documentation submitted by pharmaceutical companies and inform about remarks, contact with representatives of the companies.
student
Drug Institute
Laboratory studies connected with the title of the master’s thesis carried out in Antibiotics and Microbiology Department of the Drug Institute (now National Institute of Public Health)
Szkolenia i kursy
“PCR technique and their applications” – course
Courses in quality control – ISO 17025, preparing SOP’s and QC procedures.
Trainings on the assessment and preparation of documentation for marketing authorization organised by National Institute of Public Health and The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
National Institute of Public Health – trainings: unreliability of analytical measurements
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products – EU Pharmaceutical System and Legislation
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products – Assessment of the current IT system
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products – Needs of the current practice for herbal activity
Courses in quality control – ISO 17025, preparing SOP’s and QC procedures.
Trainings on the assessment and preparation of documentation for marketing authorization organised by National Institute of Public Health and The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
National Institute of Public Health – trainings: unreliability of analytical measurements
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products – EU Pharmaceutical System and Legislation
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products – Assessment of the current IT system
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products – Needs of the current practice for herbal activity
Edukacja
biologia, magisterskie
Szkoła Główna Gospodarstwa Wiejskiego w Warszawie
Specjalizacje
Inżynieria
Inne
Zainteresowania
ogrodnictwo
Grupy
sggw
SGGW to jedna z najstarszych polskich uczelni. Zawsze wysoko w rankingach. Otrzymała tytuł „Najbardziej innowacyjnej i kreatywnej uczelni w Polsce”.
Agencja Interaktywna Vertes
Vertes Design to nowoczesna agencja interaktywna specjalizująca się w skutecznych rozwiązaniach internetowych i marketingowych.
Pharma Market
Grupa dla osób związanych z rynkiem farmaceutycznym. Wymiana informacji, nowości w branży oraz informacji z rynku. Nowości firmy DOCS International. Osoby z ukrytym profilem nie będą akceptowan
Rejestracja Produktów Leczniczych
Grupa dla Osób, którym nieobcy jest świat rejestracji produktów leczniczych w Polsce.
