Good Manufacturing Practice Specialist

ID1029

Qualified Person (QP), API release

MSc, pharmacy, Copenhagen University
Available for: Full time, part time, tasks

Competences

  • NC/CAPA Process management.

  • Systematic problem solving (Coaching).

  • Change request process management.

  • Validation Activities (URS, Equipment Qualification, and process Qualification).

  • QP (Batch review and product release).

  • QMS implementation (procedures/templates).

  • GMP support in daily operation – shop floor.

  • Establish process for cleaning of classified areas and CNC.

Key results

  • Implementation of DDKM (Den Danske Kvalitets model) IKAS at Nørrebro pharmacy.

  • Change request and NC expert for sourcing operation at Novo Nordisk.

  • Key responsible for establishing a new process for clening of classified areas at the new Novo Nordisk warehouse.

  • Deputy manager with responsibility of 25 employees at Nørrebro pharmacy.

Software/Standards

Certifications:

  • ICH Guideline Q7 and Q10.

  • ISO13485:2016.

  • FDA 21CFR part 820.

  • IVDR.

  • Windows.

  • Microsoft Office 365.

  • QMS systems as: Agile and NovoGlow

Personal Characteristics

He does not believe that we have problems, but challenges and every challenge has a solution. Sometimes with a pragmatic approach.

As person he is loyal, values equal amount of respect from others and has the ability to stay positive in demanding periods with high work load.

He is good at communication and loves to share his experience with others. He works well in a multicultural environment where it is naturally for him to interact with people of different academic and cultural background.

He has many years of experience in the production area in the pharmaceutical and medical device industry where cGMP and compliance is his main focus.

In his spare time he enjoys fishing, play paddeltennis, coaching his son and his team mates in soccer.

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