Qualification, Validation and Operation

ID1065

Senior Qualification & Validation Expert

MSc, Parmacy, Copenhagen University
Available for: Part-time, full-time, tasks

Contact us for full CV

Competences

  • Validation, Qualification and Operation
  • CQV packages – URS, CARA, DQ, FAT, SAT, IQ, OQ, PC/PJ/PFV/PV), CV and CM.
  • Risk assessment + FMECA
  • SME in Process Cleaning of multipurpose and dedicated facilites
  • Cleaning Operation (CM)
  • QA and product release.
  • GMP, GdocP
  • Deviation handling
  • Change request process management
  • Logbooks for operation

Key results

Validation Specialist and Cleaning SME with more than more than 10 years’ experience in the pharmaceutical industry working dedicated within projects Validation and Operation.

Improved CIP validation of filters and with increase of facility manufactory capacity up to 30%.

Created specific CIP with 40% reduction of water use.

Validated a complete facility with more than 25 vessels, filters, centrifuges, pipes, wash machines, columns and more.

Design and qualification of a completely new facility with more than 110 routes.

Software/Standards

Extensive Project knowledge in compliance with following standards:

  • EMA Annex 15

  • FDA CFR 211.182

  • PDA Technical report Validation

  • Eudralex Volume 4

  • PIC validation PI 006-3

  • Health Canada GUI 0028

  • ISO 9001 QMS

  • ISO 17025 Calibration

  • ISO 22716 Risk Mitigation

  • ISO 13485:2016 Quality Management System

QMS Systems:

  • Qualitydocs, Global-lims, Novoglow.

General:

  • Microsoft Office

Personal Characteristics

He has a pleasant personality, which is creative, professional and engages with high energy and dedication. As a Lead and supervisor for more than 20 senior and junior professional he gathered a team of success that despite any challenge operates in positive, comfortable and efficient work environment.

He invented several pioneering CIP processes for complex and sophisticated equipment in the pharmaceutical industry. Innovation, optimization and development characterize the way he works.

He thrives within high level of expertise and systematical way of working that promise on time delivery and successful results.

Contact

Medicologic A/S
Arne Jacobsens Alle 15-17
DK-2300 København S
Denmark
(+45) 48 24 51 13

 contact@medicologic.com
 Medicologic-profile
Where to find us

Michael Funder
Owner / Director
(+45) 20 64 41 46
mf@medicologic.com

Lars Bo Andersen
CFO / Administration
(+45) 31 13 51 05
lba@medicologic.com