Oliver Löffler
Zaehlweg 1
34626 Neukirchen
Germany

Phone: +49-6694-910515
Fax: +49-6694-910521
Mobil: +49-170-9352600

email: oliver.loeffler(at)t-online.de

 

Education

  • Biological Technical Assistant
  • Labware Certified Consultant
  • Risk Management
  • Quality Management,
  • CSV, 21 CFR 11, GMP
  • Data security management

Professional experiences

  • Administration Quality IT Systems in regulated Pharma environment
  • Project- Management and Project lead
  • Validation of Computerized Systems in regulated Pharma environment
  • FMEA, ITIL, CAPA, Risk analysis and Management acc. Gamp
  • LIMS Rollout and Project management
  • Leadership in Quality assurance Computer systems & Applications by Novartis Vaccines
  • Local QA – eCompliance Manager by Novartis Vaccines

Own company

Line of business: Pharmaceutical, Chemical, Diagnostica, Biotechnology and Food - Industry
  • Computerized Systems validation
  • IT - Quality - und Compliance Management
  • IT - Risk- and Data Security
  • System development

Purpose of the company:
  • The IT-validation measures are the highest quality criterion for the specification, selection and introduction of quality systems and other IT systems. The implementation of these criteria means the integration of statutory requirements and the achievement of qualitative objectives of the project at a high level. We do IT Validation measures (CSV) through integrative in your company, e.g. whose know-how transfer to the employees of our customers is important to us.
  • Compliance with the relevant legislation is an important prerequisite. In the pharmaceutical sector, the rules of the American FDA, European (EU GMP Annex 11, 15) and national (AMG, MPG, BetrVerordnung Ind. Pharm applicable) standards and specifications.
  • Objective and impartial advice to the management and entrepreneurs in choosing a new IT system or the decision of validating the existing systems.

Typical projects

  • Implementation and validation of a laboratory information’s management system in a tobacco industry laboratory
  • CSV Support/Project Management/ Computer system Validation by Novartis Vaccines for a Deviation management system
  • Implementation of „Best Practices" Structure for IT Services
  • System development and Re-Validation of a Deviation management system
  • System development and enhancement to a High availability system
  • Re-Validation of a Document management system for controlled Printout of Batch Production Records
  • Upgrade/Release and Validation of a laboratory information’s management system