Jeanette Leisner Email & Phone Number

Copenhagen, Denmark

GxP coordinator supporting laboratories, animal facilites and production at SSI through ensuring compliance of equipment, utilities and monitoring facilities according to ISO and GxP standards.Tasks include preparing and maintaining associated instructions, change control, deviation and CAPA handling ,and requirement specifications for new equipment and suppliers.Furthermore, ensure that equipment and facilities continue to uphold current requirements, as well as track ongoing… Show more GxP coordinator supporting laboratories, animal facilites and production at SSI through ensuring compliance of equipment, utilities and monitoring facilities according to ISO and GxP standards.Tasks include preparing and maintaining associated instructions, change control, deviation and CAPA handling ,and requirement specifications for new equipment and suppliers.Furthermore, ensure that equipment and facilities continue to uphold current requirements, as well as track ongoing changes through requalification.Main focus areas have been autoclave validation with cycle development, support in uphplding requirements for containment areas (animal facilities), and assisting in tendors for new equipment and suppliers (autoclave, VHP chamber, Metrology, Gasses). Show less

Bagsværd

After 20+ years experiance in pharma, working with compliance, production and facility support in a GMP environment, which has included coordinating biannual shut down and restart of production as well as ensuring implementation of planed maintanance activities, well defined projects and diverse ad hoc activities for my department, pilot plant production.As equipment responsible, I ensured the stabil operation of the departments facilities and equipment including restoring functionality… Show more After 20+ years experiance in pharma, working with compliance, production and facility support in a GMP environment, which has included coordinating biannual shut down and restart of production as well as ensuring implementation of planed maintanance activities, well defined projects and diverse ad hoc activities for my department, pilot plant production.As equipment responsible, I ensured the stabil operation of the departments facilities and equipment including restoring functionality after correction of alarms and failure states.Additional support fuctions include ensuring compliance through use of deviation control, CAPA, change controls and implementation of new equipment with required qualification Keys words are GMP, QMS, SAP, maintenance, facility, qualification and validation. Show less

Key Areas – Department 276 (Cell Culture)• Aseptic techniques maintain cell bank and seeding material for production (Mammalia cells and bacteria)• Monitoring of purified water and clean steam and handling samples in LIMS• Environmental monitoring of clean rooms and handling of samples in PEMS• Laboratory support for production (cell count, CEDEX, BioProfil, pH, staining, microscopy of cells)• Identification of contaminant in production • Equipment responsible for… Show more Key Areas – Department 276 (Cell Culture)• Aseptic techniques maintain cell bank and seeding material for production (Mammalia cells and bacteria)• Monitoring of purified water and clean steam and handling samples in LIMS• Environmental monitoring of clean rooms and handling of samples in PEMS• Laboratory support for production (cell count, CEDEX, BioProfil, pH, staining, microscopy of cells)• Identification of contaminant in production • Equipment responsible for autoclave, production washer and laboratory equipment• Responsible for Trend reports for purified water Show less

Laborant _ support til pilot produktion og celle opformering

Key Areas • Aseptic techniques maintain cell bank and seeding material for production (bacteria and fungi)• Mutations technics and ELISA screening• Identification of contaminant in production • Small scale fermentation

Key area was protein characterisation and characterisation of sperm cells for stallions, bulls and boars

Laboratory student with focus area:- cell bank formations and maintenance- small scale cultivation- protein characterisation

Academy Professional -Innovation, Production And Process (2023), Projektstyring Og Innovation, 12

Laboratorietekniker, Biotechnology

Laborant, Biotechnology