Quality Assurance and Regulatory Affairs

ID1033

Senior QA & Compliance Expert

MSc. Food Science & Technology
Available for: Full time, part time, tasks

Competences

  • Audit Process Management

  • Inspection Readiness

  • Active & Certified Lead Auditor; external/internal audits

  • Gap Analyses Expert

  • Root Cause & Investigations SME

  • Quality Management| QMS elements

  • Supplier Quality Management

  • Team Management Representative

  • Experienced QP & RP

  • Expert knowledge in GMP, GDP, & ISO 9001

  • Transformational Trainer

Key results

  • Performed PAIs which contributed to a successful FDA inspection result.
  • Improved an entire QMS framework/structure through rebuilding Deviation Management, CAPA, Risk Management.
  • Developed, organized, and Facilitated workshops on the implementation of compliance initiatives.
  • Pharma warehouse extension approved.
  • Successfully trained thousands of GMP/GDP personnel.
  • Fixing broken stakeholder relationships.

Regulations/Standards/Guidance

Extensive knowledge in:

  • EU regulations: EU GMP: Regulation No. 1252/2014 and Directive 2003/94/EC, applying to active substances and medicines for human use.
  • FDA regulations: CFR 21 Part 211, Part 11, Part 210.
  • Guidelines: EU Guidelines 2013/C 343/01 Good Distribution Practice (GDP).
  • EU harmonized/internationally recognized.
  • Standards: ISO 9001, 22001.

Personal Characteristics

She is known to be detailed but at the same time pragmatic. She is structured and is a fantastic communicator (which includes listening skills). Dealing with tricky/difficult stakeholders are a breeze for her.

She has 20+ years in QA & Compliance/ Auditing and Inspection within the Pharma, Food, Health, Warehousing & Medical Devices.

In her spare time, she is currently working on her first novel (low- fantasy), learning to play the cello, doing fitness, and spending time with her 2 sons.

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