Hi, I’m
Maria Dahl Hvidkjær
Coordinator / GMP Specialist
Helsinge
Summary
Experienced Bioanalyst with more than 15 years in the pharmaceutical and healthcare industry. Strong expertise in GMP compliance, facility management support, document management systems, and process optimization. Skilled in audits, training coordination, stakeholder collaboration, and continuous improvement initiatives (LEAN, VSM, A3). Proven ability to deliver measurable improvements in efficiency, compliance, and cost savings.
Work History
Novo NordiskHillerød
Coordinator / GMP Specialist
12.2021 - Current
Job overview
- Authored and reviewed test protocols and reports.
- A3 facilitator, project coordinator, and planner.
- Edited and updated GMP documentation (QualityDOCS).
- Acted as interim team leader during period without formal manager.
- VSM 3 – Digitalization of report results: Implemented a scanning system for test results, enabling digital uploads as report attachments.
Effect: Significant reduction in manual data entry and review hours.
- VSM 4 – Optimization of Customer Complaint workflows: Introduced 5S principles, NNPlanner coordination, PowerBI tracking, and daily stand-ups.
Effect: KPI (90% cases handled within 5 days) improved from 76% average to 95%.
Novo NordiskMåløv
SAP & Documentation Specialist
08.2016 - 12.2021
Job overview
- Core contributor to establishing the new oral tablet production facility.
- Responsible for SAP system configuration and support.
- Document Owner (DV) and CR Case Owner.
- Training coordinator ensuring GMP compliance across teams.
- Editor Expert in QualityDOCS system.
- Achieved cLEAN® 2 Star certification in 2020.
- Facilitated A3 workshops and continuous improvement projects.
- VSM 1 – Column management for HPLC/UPLC systems: Implemented a control system ensuring only functioning and durable columns were in use.
Effect: Substantial savings in downtime and waste.
- VSM 2 – Accelerated onboarding program: Designed structured mentoring and training plans.
Effect: Average onboarding time reduced from 5 months to 3 months.
Steno Diabetes Center, GentofteGentofte
Bioanalyst
12.2005 - 08.2016
Job overview
- Implemented migration of laboratory documentation into NovoGlow IT system.
- Collaborated with the Danish National Institute of Public Health on large-scale health studies in Greenland, establishing temporary labs in remote areas.
- Conducted ultrasounds, sampling (blood, urine, nails), and lifestyle interviews.
- Educated newly diagnosed diabetic patients in blood glucose monitoring devices.
- Conducted routine analyses, physiological examinations, and research projects.
Amager Hospital, CopenhagenAmager
Bioanalyst
08.2004 - 12.2005
Job overview
- Performed standard biochemical laboratory analyses and supported diagnostics.
Birth Year
16/09/79
Languages
Danish
Native language
English
Proficient (C2)
C2
References
References available upon request.
Education
Paum InstituteCopenhagen
Bachelor of Science from Bachelor of Biomedical Laboratory Science (Bioanalyst)
08.2001 - 08.2004
Certification
cLEAN® 2 Star (Novo Nordisk, 2020)
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