Dr. Andreas Ockenfels

Pharma Consulting

About me

Experience

  • My experience is based on working as a permanent employee and since then on several projects as an external consultant in various areas of quality management, quality control and manufacturing. 
  • National and international GLP and GMP guidelines and ISO standards were the regulatory framework. 
  • The products were small chemical entities or large biotechnologically produced molecules. This included the production of active ingredients, finished products and the packaging of pharmaceuticals or medical products. Dosage forms were parenterals, tablets, capsules, syrups, sprays, etc.
  • I have conducted many inspections for GLP or GMP certification and re-certification by authorities including the US FDA as well of many audits by international clients at various sites.
  • I have experience of auditing suppliers at national and international level in the areas of quality control or production to GLP, GMP, ISO 9001 or ISO 13485.
  • I have extensive experience of managing quality assurance departments under GLP and GMP, also on a multi-site basis.
  • The wide range of projects has allowed me to increase my experience in planning, managing and adapting projects, both as a leader and as part of very different teams.
  • I enjoy training. Over the years I have delivered many training courses, both internally and externally or at international events.

Skills and Competences

  • Quality management and quality control: from working with pharmaceutical products and APIs (small molecules and biopharmaceuticals), or medical devices according to international regulations (EU, US, etc.) with management responsibility
  • Project management: through the implementation or optimisation of quality systems for quality control and manufacturing, remediation activities, method or process transfers
  • Scientific and technical background: process-oriented approach, solving complex and interrelated problems,
  • Communication, including facilitation and presentation: strong communication skills and an outgoing and confident personality
  • Training: practical, needs-based, didactically structured, methodologically sound
  • Flexible, with a precise, structured and interdisciplinary way of working, hands-on mentality
  • Proven ability to work under pressure, highly motivated
  • Client-oriented, highly competent negotiation skills in German and English, with intercultural competence
  • Independent and solution-oriented approach

Curricilum Vitae

Employment History

since Oct 2011

Independent Consultant

Oct 2008 – Oct 2011

Director Quality Management, Charles River Pharmaceutical Services GmbH, Erkrath, Germany;

Service: External quality control under GLP and GMP, in particular of biopharmaceutical starting materials, intermediates, active pharmaceutical ingredients and final products.

  • Head of the GLP and GMP quality unit at the site in Erkrath, and between 2005 and 2008 also of the GLP Quality Unit at the Cologne site
  • Maintenance and improvement of the quality system in accordance with national and international GLP and GMP laws and regulations and costumers requirements.
  • Responsible for projects to implement, reorganise and harmonise quality management systems in manufacturing and quality control at various sites
  • Responsible for inspections by international clients and authorities (e.g., US FDA) as well as qualification of subcontractors
  • Support for validation of bioanalytical methods.
Nov 2002 – Sep 2008

Director Quality Management, NewLab BioQuality AG, Erkrath, Germany;

Service: External quality control under GLP and GMP, in particular of biopharmaceutical starting materials, intermediates, active pharmaceutical ingredients and final products.

  • Head of the GLP and GMP quality unit at the site in Erkrath, and between 2005 and 2008 also of the GLP Quality Unit at the Cologne site.
  • Maintenance and improvement of the quality system in accordance with national and international GLP and GMP laws and regulations and costumers’ requirements.
  • Responsible for projects to implement, reorganise and harmonise quality management systems in manufacturing and quality control at various sites.
  • Responsible for inspections by international clients and authorities (e.g., US FDA) as well as qualification of subcontractors for their compliance.
  • Support for validation of bioanalytical methods.
Mar 2001 – Oct 2002

Quality Assurance Manager, NewLab BioQuality AG, Erkrath

  • Review and release of quality related documents: protocols, SOPs, reports, certificates of analysis, change- and deviation control documentation, equipment qualification
  • Performance of internal and external audits
  • Support for customer and regulatory audits
Jan 1996 – Dec 2000

Chemist (part time)

Landers-Kreislaufwirtschaft, Wesel/Rhine

Jan 1991 – Sep 1992

Mechanic and Salesperson,

TSAutomobile, Sinzig/Rhine, repair and selling of cars

Sep 1985 – Jun 1988

Training as laboratory assistant,

Institut for Organic Chemistry and Biochemistry, University of Bonn, Germany

Education

Apr 1998 – Jan 2001

Doctorial thesis, Max Planck Institut for Radiation Chemistry, Mülheim/Ruhr;

Doctorate, Gerhard-Mercator University Duisburg, supported by a research grant from the Friedrich-Ebert foundation, Bonn

Dec 1997

Award for diploma thesis by the rectorat of the Gerhard-Mercator University and the University Society Duisburg

Oct 1991 – Aug 1997

Study of chemistry, Gerhard-Mercator-University Duisburg,

diploma thesis at the Max-Planck-Institute for Radiation Chemistry, Dipl.-Chem.

Dec 1990

General qualification for university entrance, Kaiserslautern

Aug 1988 – Jun 1989

Advanced technical college entrance qualification, Gewerbliche Bildungsanstalten der Stadt Bonn

Sep 1985 – Jun 1988

Training as a chemical laboratory assistant, University of Bonn

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