ID1030
Senior Consultant Management and Compliance
B.Sc. Clinical Chemistry
Available for: Full time, part time, tasks
Contact us for full CV
Competences
-
Project Management
-
Quality Management
-
Medical Device
-
People leadership and management
-
Process mapping
-
cGMP
-
Performance management
-
Change Management
Key results
Project Management as responsible person for implementation of large projects. E.g., construction and implementation of a pharmaceutical production site. Or as member of top management responsible for the PMO in Biogen.
Change Management leading people towards major changes with success e.g., Implementation of LEAN leadership in several sites in Novo Nordisk.
QMS and Technical File writing and updating QMS for LEO Pharma to fit a changed organization.
Significant leadership skills leading teams and departments over the years in both quality control, aseptic production, and in-vitro production
Standards
-
MDR 2017/645
-
MDD 93/42/EC
-
ISO13485
-
ISO14971
-
FDA regulation [CFR part 820]
-
cGMP
Personal Characteristics
She is a competent leader, who takes responsibility for the people and the tasks from bottom to top.
She is a go-doer and has a no-nonsense attitude always finding a positive and constructive solution to a problem.
She is an experienced consultant and is highly appreciated by her clients.
Privately she enjoys reading books, watching films and theatre, listening to concerts and records, and off course being a grandmother having fun with both dolls and LEGO.
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