Birte Søgaard Andersen Email & Phone Number

• Docoment Controller at Fujifilm Diosynth Biotechnologies
• Co-ordinating document control requirements within the project
• Develop and administer detailed design
• Create and maintain document system overview
• Document Control Management for engineering deliverables
• Coordinate with EPCM partners on document control

Hovedstaden, Danmark

• Maintenance of data in Veeva Vault RIM
• Ensure that Veeva Vault RIM is GxP compliant
• Handle specific Veeva Vault RIM projects
• Global Regulatory Affairs Training Coordinator training
• Instructor in GxP and LearnIT
• Support to Veeva Vault RIM users

Hovedstaden, Danmark

• Support for updating Standard Contractual Clauses when transferring data to third countries
• Contact vendors and obtain information and signatures for contract amendments e.g., related to updated Data Transfer Agreements
• Assist in the organization and maintenance of formal privacy documentation for the purpose of internal/external audits
• Support and guidance to intern stakeholders in regard to GDPR

Hovedstaden, Danmark

• Quality control of data
• Document control of Pharmacovigilance ICSR cases
• Data migration between companies

Bagsværd

• QA batch release and status assignment of secondary packaging in SAP ECC & PRISM systems
• QA approval of SAP master Data in SAP ECC
• QA approval of MPO in PRISM
• Occupational Health and Safety Representative
• Ensure compliance by observing regulations/guidelines, standards and internal specifications
• Review and archiving of relevant documentation in OmNiRim

Gentofte

• Preparing of test protocols in accordance to GMP
• Ensure documentation is in compliance with described specifications

Mødrup

Kvistgaard Denmark

• Reorganization and structuring of GMP + GCP archive
• Recovery and lending of GMP documents
• Registration and distribution of SOPs
• Updating and management of SOP training records
• Filing of documents approved by QA
• Reception and preparation of original documents from other archives

Copenhagen Denmark

• Verification and checking of data
• Systematisation and recording data
• Updating and maintaining records, thesaurus and databases
• Indexing and catalogue
• Preparation of search profiles for external user

Humlebaek Denmark

• Classification / catalogue, verifying, locating and borrowing from Danish and foreign libraries
• Magazine Registration / Administration
• Book purchases
• Classification and registration materials
• Archiving
• Information and literature search

Hoersholm, Denmark

• Establish guidelines for and organizing a historic company archives
• Classification and registration materials
• Work with the requirement specifications for implementing a archive database
• Train colleagues in use of archive database and responsible for the continuous validation of the database
• Hold presentations for new employees on company history
• Contact and cooperate with affiliates from around the world

Bagsvaerd, Denmark

• Classification / catalogue, verifying, locating and loans from Danish and foreign libraries
• Introduction and tour for staff and visiting scholars in English and Danish
• Project manager for the relocation of journals: Two teams of 2 persons
• Contact and cooperate with affiliates from around the world
• Magazine Registration / Administration
• Media Monitoring for Novo Nordisk and its business areas

Gentofte, Denmark

• Book purchases
• Classification / catalogue, authentication, location and loan of journals and books
• Magazine Circulation

Gladsaxe, Denmark

• Magazine Circulation
• Classification / catalogue, authentication, location and loan of journals and books.
• Project manager for the systematisation of article orders (own initiative)

Gdpr Coordinator And Personal Data Specialist

Project Management With Prince2 Foundation, 10

Librarian, Db, Library And Information Science, Db

Mathematical/Scientific Line, Natural Sciences