Consultants – Senior Consultants

Gitte Emde

Experiences:

  • > 20 years of experience in the pharmaceutical industry
  • Clean room qualification
  • Environmental Monitoring
  • Lab equipment
  • Supply systems
  • Insulin production
  • Authority Inspection
  • GMP

+45 4038 5512

John Albertsen

Experiences:

  • > 20 years of experience in the pharmaceutical industry
  • Pharmaceutical and Biotechnological Processes
  • Medical equipment industry
  • Supply systems
  • Project Management
  • Quality activities
  • Authority Inspections
  • GMP

+45 2123 5168

Karina Nikolajsen

Experiences:

  • > 10 years of experience in the pharmaceutical industry
  • Project Management
  • Quality Activities
  • Authority Inspections
  • GMP

+45 4240 7575

Keld Andersen

Experiences:

  • > 15 years of experience in the pharmaceutical industry
  • > 25 years of experience with QA and audit
  • Project Management
  • Validation / qualification
  • Processes / supply systems
  • Authority Inspections
  • GMP

+45 2533 7126

Lizette Carmel

Experiences:

  • > 20 years of experience in the pharmaceutical industry
  • Development and manufacture of vaccines
  • Environmental Monitoring
  • Monitoring of water and steam
  • Production support (deviations, changes, problem solving, etc.).
  • Validation / qualification
  • Supply Systems
  • Authority Inspection

+45 2078 1677

Phat Huynh

Experiences:

  • > 10 years of experience in medical equipment
  • > 5 years of experience in the pharmaceutical industry
  • Qualification / validation of equipment and processes
  • Specialist in sterilization
  • Gamma / beta sterilization according to ISO 11137
  • EO sterilization according to ISO 11135
  • FDA 21 CFR Part 820
  • Design control
  • Risk analysis

+45 2288 3233

Stig Nielsen

Experiences:

  • > 20 years of experience in the pharmaceutical industry
  • Equipment qualification
  • Design Control
  • GMP

+45 5383 4859

Ulf Damgaard Nielsen

Experiences:

  • >15 years of experience in the pharmaceutical industry
  • Validation of IT based automation systems
  • Validation of ERP systems and computer systems
  • Serialization and Track & Trace
  • Qualifying of infrastructure
  • Quality aktivties incl. IT QA, IT QC; Validation Management, Training
  • FDA 21 CFR Part 11; EU Volume 4 Annex 11 og 15
  • GAMP5, cGxP, VMP/R; VPL/R; URS; RA; DQ, FAT; SAT; IQ; OQ; PQ

+45 2383 6730

Experiences:

  • >10 years of experience in the pharmaceutical industry
  • Project Management
  • GMP
  • Qualification and validation of proces equipments

+45 2913 2445

Jesper Nikolajsen

Experiences:

  • >20 years of experience in the Pharmaceutical industry
  • API Production and support
    • Freeze dryer, HPLC, Kryst, Modifications etc.
    • Derivations, CR, APR, VVS, SOP etc.
  • Design and requirements documentation
    • Risk analysis, IRS, FRS, URS, RTM
  • Qualification and validation of equipments and processes
    • FAT, SAT, DQ, IQ and OQ
  • Cleaning validation and Monitoring
    • Design, Riboflavin, Cleaning PQ and CV
  • Project experience
  • Lean Manufacturing
  • GMP Inspections
  • Sattline, DeltaV, novoLIMS, E-tims, Novoglow etc.

+45 4240 9060

Curriculum Vitae

For more information or requesting Curriculum Vitae in English:

+45 5945 1368