Quality Assurance and Regulatory Affairs
Senior QA & Compliance Expert
MSc. Food Science & Technology
Available for: Full time, part time, tasks
Contact us for full CV
- 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
- 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.
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.
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.
Arne Jacobsens Alle 15-17
DK-2300 København S
(+45) 48 24 51 13
Where to find us