Anke (Christel) Zampich

Consultant

Anke Zampich
Leverkusen, Germany

Experience

Jan 2010 - Present
16 years 1 month
On-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 months
Neumarkt 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 months
Neumarkt 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 months
Neumarkt in der Oberpfalz, Germany

Pharmaceutical Representative (Medical Practitioner and Pharmacy)

Bionorica AG

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
Native
English
Advanced

Certifications & 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

Need a freelancer? Find your match in seconds.
Try FRATCH GPT
More actions

Similar Freelancers

Discover other experts with similar qualifications and experience

Benjamin Kraus
Benjamin Kraus

MDR Transition with PRRC-Function

View Profile
Josipa Ljubicic
Josipa Ljubicic

CEO/GxP Auditor

View Profile
Monika Weber
Monika Weber

Quality Specialist

View Profile
Juergen Mehring
Juergen Mehring

Freelancer

View Profile
Thomas Roßner
Thomas Roßner

Project Manager in Animal Husbandry and Feed

View Profile
Marcel Maurer
Marcel Maurer

Quality Management Expert / Regulatory Affairs

View Profile
Niels Adams
Niels Adams

Consultant: Translational Sciences

View Profile
Desalegne Syit
Desalegne Syit

Medical Device Auditor (ISO 13485, ISO 9001)

View Profile
Elena Chis
Elena Chis

Plant Quality Manager

View Profile
Jürgen Schmickler
Jürgen Schmickler

Manager Manufacturing Operations USP

View Profile
Klaus Finneiser
Klaus Finneiser

Freelancer

View Profile
Timur Güvercinci
Timur Güvercinci

Senior Quality Project Expert and Consultant in the Pharmaceutical Industry

View Profile
Alexander Sänn
Alexander Sänn

Owner and Managing Director

View Profile
Manuel Kathofer
Manuel Kathofer

Overall Project Manager for the Global Roll-Out of a Quality and Document Management System

View Profile
Andreas Seidl
Andreas Seidl

Interim Head of Risk Management and Usability

View Profile
Jean Schikora
Jean Schikora

ISO 27001 Implementation

View Profile
Gerd Gembatzke
Gerd Gembatzke

Head of Quality Management and QM Taskforce

View Profile
Kai Müller
Kai Müller

Head of Quality Assurance

View Profile
Sandra Klinkenberg
Sandra Klinkenberg

Webinar Leader - Blackout Prevention and Preparation

View Profile
Mirko Haucke
Mirko Haucke

Cybersecurity Manager

View Profile
Anton Schieting
Anton Schieting

Consultant for the ISO 9001 Quality Management System

View Profile
Hans Spichiger
Hans Spichiger

Interim Manager, Consultant, Facilitator

View Profile
Federico Leefhelm
Federico Leefhelm

ISO – Senior Consultant Quality & Information Security

View Profile
Estelle Kamwa
Estelle Kamwa

Document Management / Document Controlling Specialist

View Profile
Dieter Hummitzsch
Dieter Hummitzsch

HSE Consultant (Field Core / General Electric), Stadtwerke München GUD2 Power Plant

View Profile
Bettina Fischer
Bettina Fischer

Quality Management Consultant

View Profile
Andreas Linder
Andreas Linder

Freelancer for Quality, Environmental and Occupational Safety Management

View Profile
Thomas Kupfer
Thomas Kupfer

Consultant/Coach ISO/SAE 21434 / UNECE R-155

View Profile
Eckart Hillenkamp
Eckart Hillenkamp

Founder

View Profile
Joseph Amorin
Joseph Amorin

Business Operations and ASPICE Quality Assurance

View Profile