Recommended expert
Anke (Christel) Zampich
Consultant
Experience
Jan 2010 - Present
16 years 2 monthsOn-site
Consultant
QA-System - QA-GxP Consulting
- GCP audits: ATMPs
- Phase I–IV study audits
- Quality assurance in Biocell products
- System audits and on-site audits
- Quality assurance interim management
- Vendor qualification audits
- Document audits
- Mock audits and for cause audits
- GCP inspection readiness
- Mock inspection audits
- Inspection coordination/management and preventative actions
- SOP development, review and training
- GVP audits
- GCP training
- Medical devices
- VICH consulting: supporting study management and VICH audits
Oct 2002 - Dec 2009
7 years 3 monthsNeumarkt in der Oberpfalz, Germany
Clinical Auditor/GCP Manager
Bionorica AG
- SOP training and in-house GCP training
- Advice in clinical trials
- Proof of inspections readiness – GCP (Clinical Research)
- Proof of inspections readiness – PV (Pharmacovigilance)
- Organization and conducting of internal and external system and study audits
- Implementation of study management system (Pharmacovigilance)
- SOP development and review
Jul 1996 - Sep 2002
6 years 3 monthsNeumarkt in der Oberpfalz, Germany
Clinical Monitor (CRA)
Bionorica AG
- SOP training
- Assistant project management
- Clinical trials phase III–IV
- SOP development
Apr 1995 - Jun 1996
1 year 3 monthsNeumarkt in der Oberpfalz, Germany
Pharmaceutical Representative (Medical Practitioner and Pharmacy)
Bionorica AG
Industries Experience
See where this freelancer has spent most of their professional time. Longer bars indicate deeper hands-on experience, while shorter ones reflect targeted or project-based work.
Experienced in Pharmaceutical (31 years) and Biotechnology (16 years).
Pharmaceutical
Biotechnology
Business Areas Experience
The graph below provides a cumulative view of the freelancer's experience across multiple business areas, calculated from completed and active engagements. It highlights the areas where the freelancer has most frequently contributed to planning, execution, and delivery of business outcomes.
Experienced in Quality Assurance (29.5 years), Research and Development (13.5 years), Project Management (6 years), and Sales (1 year).
Quality Assurance
Research and Development
Project Management
Sales
Summary
Experienced QA System Consultant with over 25 years of expertise in GxP-regulated environments (GCP / GVP), including clinical trial phases I–IV, global quality management, SOP development, and regulatory inspections. Specialized in quality assurance for both human and veterinary medicine, as well as medical devices.
Skills
- Ms Word
- Excel
- Power Point
- Ms Project
- Ms Access
- Endnote 6
Languages
German
NativeEnglish
AdvancedCertifications & licenses
Pharmacovigilance Audits
Inspections of clinical trials by federal authorities, EMEA, FDA
Standard Operating Procedures
12th amendment to the German Medicines Act (AMG)
FDA Inspections of Clinical Trials in Europe
EndNote 6
Quality Assurance in Clinical Research
Clinical Site Audits
MS ACCESS 97
Project Management in Clinical Trials
Monitoring of Clinical Trials with Special Focus on ICH-GCP
Planning and Evaluation of Clinical Trials
Source Data Verification in Clinical Trials
Profile
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Frequently asked questions
Do you have questions? Here you can find further information.
Where is Anke based?
Anke is based in Leverkusen, Germany.
What languages does Anke speak?
Anke speaks the following languages: German (Native), English (Advanced).
How many years of experience does Anke have?
Anke has at least 31 years of experience. During this time, Anke has worked in at least 4 different roles and for 2 different companies. The average length of individual experience is 8 years and 9 months. Note that Anke may not have shared all experience and actually has more experience.
What roles would Anke be best suited for?
Based on recent experience, Anke would be well-suited for roles such as: Consultant, Clinical Auditor/GCP Manager, Clinical Monitor (CRA).
What is Anke's latest experience?
Anke's most recent position is Consultant at QA-System - QA-GxP Consulting.
What companies has Anke worked for in recent years?
In recent years, Anke has worked for QA-System - QA-GxP Consulting.
Which industries is Anke most experienced in?
Anke is most experienced in industries like Pharmaceutical and Biotechnology.
Which business areas is Anke most experienced in?
Anke is most experienced in business areas like Quality Assurance (QA), Research and Development (R&D), and Project Management. Anke also has some experience in Sales.
Which industries has Anke worked in recently?
Anke has recently worked in industries like Biotechnology and Pharmaceutical.
Which business areas has Anke worked in recently?
Anke has recently worked in business areas like Quality Assurance (QA).
Does Anke have any certificates?
Anke has 13 certificates. Among them, these include: Pharmacovigilance Audits, Inspections of clinical trials by federal authorities, EMEA, FDA, and Standard Operating Procedures.
What is the availability of Anke?
Anke is immediately available full-time for suitable projects.
What is the rate of Anke?
Anke's rate depends on the specific project requirements. Please use the Meet button on the profile to schedule a meeting and discuss the details.
How to hire Anke?
To hire Anke, click the Meet button on the profile to request a meeting and discuss your project needs.
Average rates for similar positions
Rates are based on recent contracts and do not include FRATCH margin.
1000
750
500
250
Market avg: 740-900 €
Market avg: 740-900 €
The rates shown represent the typical market range for freelancers in this position based on recent contracts on our platform.
Actual rates may vary depending on seniority level, experience, skill specialization, project complexity, and engagement length.
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