CV
Joke Dijkstra-Hogen Esch
|
1984–1990 |
Atheneum CSA te Aalten |
|
1990–1995 |
RUG Groningen – Farmacie |
|
1995–1997 |
|
SKILLS & COMPETENCES
Process Improvement – Strategic Planning – Verbal & Written Communication – Attention to Detail – Thoroughness – Dealing with Complexity
| GMP | ⭐⭐⭐⭐⭐ |
| GCP | ⭐⭐⭐⭐ |
| ISO 9001 | ⭐⭐⭐⭐ |
| ISO 15189 | ⭐⭐⭐⭐ |
| ISO 17025 | ⭐⭐⭐ |
| ISO 7396 | ⭐⭐⭐⭐⭐ |
| LEAN SIX SIGMA | ⭐⭐⭐⭐ |
| GAMP 5 | ⭐⭐⭐ |
BUSINESS EXPERIENCE
| 2018–present Auditor / Consultant QAble, Drachten |
-Services include audits, management support, training, coaching and advice on quality-related issues, risk management, validations and lean six sigma.
| 2012–2018 Pharmacist Quality Assurance / Qualified Person University Medical Center Groningen (UMCG), Groningen |
-Managing QA systems to define, implement and assure compliance to appropriate (regulatory) guidelines regarding pharmaceutical practices
-Involved as Qualified Person in development and manufacture of (biotechnological) drugs
-Planning, execution and monitoring of activities regarding medical gases
-Planning, execution and monitoring of quality related activities regarding pharmaceutical patient care and clinical research.
| 2007–2012 QA Compliance Manager / Qualified Person DSM Biologics (DSM Pharmaceutical Products), Groningen |
-Responsible for final disposition to customers of cell banks and bulk products and managing relating activities (Qualified Person)
-Advising to project organization and customers on all relevant cGMP matters and assures appropriate cGMP level of project activities
-Managing QA systems to define, implement and assure compliance to cGMP policies for these systems, including proposing and implementation of improvements
-Providing assistance and informing departments about changes in regulatory guidelines and supporting customers in regulatory guidelines related to the submission and maintenance of their product applications and approved licenses.
-Hosting FDA and EMA audits.
| 2004–2007 Clinical Trial Pharmacist Xendo Drug Development, Groningen |
-Management of Pharmacy section of Clinical Pharmacology Unit
-Responsible for all aspects of production and accountability of investigational medicinal products and other drug products used during clinical studies
-Implementation of new techniques within pharmacy section
-Release of drug products for clinical use (Qualified Person)
| 2002–2004 Manager Medical Department Bional Holding, Gorredijk |
-Management of Medical Department, responsible for Research & Development, Regulatory Affairs, Quality Assurance, and Training & Education divisions.
-Responsible for quality system and regulatory submissions
| COURSES |
2017 Appreciative enquiry for compliance audits (Kerteza)
2015 Education Lean Six Sigma Black Belt IBIS/UVA University of Amsterdam
2015 Course ISO 17025 (Kerteza)
2013 Masterclass NEN-EN-ISO 15189 (NEN-ISO/Kerteza)
2013 Masterclass Medische Gassen NEN-EN-ISO 7396-1
2013 Internal audit+ training for advanced auditors (V-KAM)
2012 Training RvA/CCKL guidelines (Kerteza)
2012 Course Train the GMP Trainer (DBA-NSF)
2010 Course Human Failure Analysis Techniques (DBA-NSF)
2010 Course Viral Safety for Biotechnologicals (Newlab)
2009 PDA Workshop Monoclonal antibodies (PDA)
2008 Statistics (DSM)
2008 Course Drug Regulatory Affairs (RXN Regulatory Affairs)
2008 Education BODL Module 4: “Biotechnology” at Delft University of Technology
2007 Forum/Course Qualified Person (QP Association)
2006 Course “GMP advanced” (Xendo Drug Development Services)
2005 Course Process Analytical Technology (
2005 Course Good Clinical Practice (Xendo Drug Development Services)
2004 Course GMP (Xendo Drug Development Services)
2004 Course “Good Clinical Practice” (Groningen University Institute for Drug Exploration)
2003 Course “GMP Middle Management” (PCS)
2002 Course “Good Research Practices (GCP/GLP)” Rijks Universiteit Groningen
2000 Management education for pharmacists (2 year education)
| INVITED LECTURES AND TEACHING |
2015 Risk management for quality professionals at UMCG
2012-2018 Hospital Pharmacy at University of Groningen regarding GMP guidelines, quality management and medical gases
2011-2013 Course Good Manufacturing Practice (Wenckebach)
2007-2012 Several in-house lectures regarding quality and regulatory affairs
2002 International Phytotherapy Conference at Lithuania
2002-2003 Phytotherapie at University of Groningen