Ellen Merete Kolderup Email & Phone Number

Ludwigshafen, De

0661 Oslo, No

Managing the QP and QC teamSubstitute for the VP Quality & Regulatory AffairsQP-API since June 2017Responsible for approval/rejection of raw materials, packaging and APIResponsible for compliance to current regulations for pharmaceutical production and distributionResponsible for deviation/CAPA handlingResponsible for the QC laboratory and continously improvement wrt quality, EHS and efficiencyResponsible for stability testing

0661 Oslo, No

Heading QA, QC and Regulatory AffairsSuperior responsibility for Quality based on current regulations for GMP and GDPSuperior responsibility for Quality Management Review and Quality Risk ManagementBudget responsibility for the Quality departmentSuperior responsibility for a consistant SOP systemSuperior responsibility for training within the Quality department and participating in training in other departmentsSuperior responsibility for preparation of regulatory documentation Superior responsibility for implementation of changes i close cooperation with the production departments

0661 Oslo, No

Managing the QP teamSubstitute for the VP Quality & Regulatory AffairsQP-API since June 2017 Responsible for approval/rejection of raw materials, packaging and APIResponsible for compliance to current regulations for pharmaceutical production and distributionResponsible for deviation/CAPA handling

- Managing an analytical method group - Managing a pharmacopeial (Ph.Eur., USP, JP) compliance group - Development and validation of analytical methods (GC, HPLC, spectroscopy, titration etc.)- Responsible for Contract laboratories (agreements, documentation etc.) performing advanced analyses (dioxins, PCBs, PBDEs, chlorinated pesticides by HRGC-HRMS) . Preparation of regulatory documents

- Managing a pharmacopeial (Ph.Eur., USP, JP) compliance group - Development and validation of analytical methods (GC, HPLC, spectroscopy, titration etc.)- Responsible for contract laboratories (agreements, documentation etc.) performing advanced analyses (dioxins, PCBs, PBDEs, chlorinated pesticides by HRGC-HRMS) . Preparation of regulatory documents

- Temporary position as Quality Control Manager- Responsible for daily management of QC department according to GMP- HMS responsible for QC department

- Responsible for method development, optimization and validation (GC, HPLC, spectroscopy, titrimetri) - Responsible for instrument qualification (HPLC, FT-IR)

- Managing an analytical instrument qualification group- Perfoming analytical method validations- Performing analysis (HPLC, CE)- Responsible for OOS handling

- Responsible for daily managing of Drug Development Project- Analysis Manager for Drug Development Project- Responsible for analytical method development and validation- Performing method validations and other analytical analysis (HPLC, IC)

- Performing method validations (HPLC) for MR contrast agents - Performing analysis, method development and validation within particle characterization techniques (Coulter Counting, lazer light diffraction, acoustic attenuation, densitometri) of MR agents and ultrasound contrast agents

Cand. Scient., Organic Analytical Chemistry

Master'S Degree, Analytical Chemistry