Highly experienced in QA & Compliance with +20 years of experience in the pharmaceutical industry (+16 years in QA)
Expert for GCP audits, consulting on strategic QA processes, training, and documentation for clinical and investigational drugs
Hands-on freelancer for operational day-to-day tasks, well versed in auditing, inspection readiness, vendor qualification, CAPA Management, Deviation Management, SOP Development/Review/Training, monitoring quality checks
We already recruited her, with excellent feedback
Select your region & language
Our content and services may vary by location.
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Overview
- Availability
- Upon request, remote & on-site for audits
- Qualification
- Continuous GCP (GVP) trainings, numerous certificates (QA/Audit-related)
- Language Skills
- German (native), English (business fluent)
- Relevant Expertise
- Quality Assurance, GCP, GVP, Auditor (+185), Auditee (+25), Vendor Quality Oversight, Vendor Qualification, CAPA, Quality Management, SOP Development, Phase I-IV, TMF Audits, Trainings, EU, FDA, Pharma, Biotech
Key-Facts
Audits
Interim Lead- & Co-Auditor (over 185 Audits)
Phase I Unit Audits
Document audits, e.g. CSR audit, protocol audit etc.
System audits
Study site audits
Pharmacovigilance System Audits (global and local)
Pharmacovigilance Qualification Audits
Mock-, for Cause, Inspection Audits
As Auditee (over 25)
Authority Inspections
Vendor Qualification Audits
Countries
Interim Lead Auditor: Germany, Austria, Russia, Bulgaria, Poland, Serbia, Italy, India, Romania, United Kingdom, France, Belgium, Netherland, Czechia, Switzerland,
Co-Auditor: USA, Mexico, Brazil
Audit Standards
ICH-GCP
EU- and national regulatory requirements
EU regulatory requirements for e.g. Clinical Trials / Pharmacovigilance
VICH Guideline
Relevant FDA CFR Parts
FDA Title e.g. 21 CFR part e.g. 11, 50
applicable Standard Operating Procedures
DIN EN ISO 9001:2000
ISO13485 / ISO14971 and Medical Devices Directive
Extract from previous activities
International Pharma Companies
(Big Pharma, SME, Biotechs, Start-Ups)
Line Management - Quality Assurance (GCP/GCLP/GMP)
Supervision & Staff Management
Quality Assurance Implementation & Monitoring
Vendor Quality Oversight
Quality Risk Assessment
EMA and Local Authority Inspections (GCP/GCLP/GMP)
Inspection readiness
Inspection preparation and conduct
Global GxP Coordinator
Global QA Management
Total Quality Management - TQM
Global SOP Management
Global CAPA Tracking
QA Manager Biotech Company
SOP Development, Review and Training
Oversees adherence to SOPs
QA GCP Audits
CAPA tracking
Vendor recruitment
Vendor Audits
Plausibility checks of study documents, e. g. CRF and study protocol
GCP Training of employees
Proof of Inspection for Clinical Research
Software Development Company: QA Manager
QA Consulting
Internal Audits
Audit Consulting
SOP Review
FDA 21 CFR part 11
CDISC Standard
GCP-Training
SOP Development, Review and Training
Oversees adherence to SOPs
QA GCP Audits
CAPA tracking
Proof of Inspection for Clinical Research
Competent Authority / EMA Inspection
Pre-Inspection Audits
SOP tracking
CAPA tracking
Preparation and support during and after the inspection
Development of SOPs
SOPs for Investigational Sites
Monitoring Quality Checks
Review of monitoring and investigator site during an on-going clinical trial, 10 investigational sites
Development of Modular GCP Training System
Development and review of approximate 40 modules for GCP training for investigators, study nurses and CRAs
Project Management in an International and Multicenter Clinical Trial in Veterinary Medicine (USA, Germany), approx. 10 Sites, Phase I
Quality Assurance check of study documents, e. g. study protocol, CRF, diary
SOP review and development
Project Management in an International and Multicenter Clinical Trial in Veterinary Medicine (3 Countries, approx. 20 Sites, Phase III)
TMF Audit
SOP review and development
CAPA tracking
GCP Training of employees
Review of Monitoring Reports
Proof of VICH- Inspection for Clinical Research
SOP review and development
GCP Training
Internal Audit