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Summary

Aseptic Excellence Partner (AEP) is a service providing company for the life science industry that guides and supports companies in quality risk mitigation in product development, production and distribution of high value sterile products. The ambition of the company is to become the partner of choice in sterile products manufacturing for the global life science industry, with specific focus on biopharmaceutical and biotechnological companies. The organization's philosophy is based on establishing pragmatic and tailored made approaches in order to provide solutions that add value and increase profitability while complying with strict quality requirements and regulations. AEP supports and guides his customers through following areas in primary and secondary manufacturing/quality operations: GMP Compliance: - Support for Audit readiness, assessment and remediation - Identification and Mitigation of Quality Risk in Aseptic Processes and Design - Observation and guidance in aseptic best practices - Training services for Aseptically processed product - Guidance in contamination control, including cleaning & disinfection guidance - CAPA, deviation management support. - Support in Validation Life Cycle Management. - Revision, creation and designing documentation systems Process/Technology: - Problem solving, risk assessment and Process Improvement in aseptic manufacturing. - Extensive expertise in lyophilization and aseptic filling technology - Technology Transfer for manufacturing processes. - Providing leadership for the design of manufacturing facilities. Industrial and Quality Operations Management: - Mentoring/coaching on the job for all roles and levels in Quality and Operational environment. - Interim management/ transition management. - Project Management

Experiences

Current Experience

  • Owner and founder
    Since May 2015

Past Experience

  • Plant Operations Manager Novartis ( ALCON)
    January 2013 --- April 2015

  • Director Secondary Manufacturing ( Formulation/Aseptic Filling /Lyophilization)
    June 2007 --- August 2011

  • Fill/Finish Manager
    January 2001 --- May 2007

  • Lyophilization Supervisor
    September 1997 --- January 2001

  • Foreman DownStream Processing
    October 1986 --- August 1997

Knowledge

LinkedIn Assessment :
Aseptic ProcessingBPFSecteur pharmaceutiqueTransfert technologiqueValidationCAPAPharmaceutical Industry

Education

  • Bachelors Biotechnology in Biotechnology from Hoge School Gent in 1991

Area / Region

Antwerp, Belgium

Others

Driving License
  • No