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Robert Sven Jechlitschka

Angestellt, Director of Quality Assurance and Development, qualified person, Schwabe Pharma Mexico
Cuernavaca, Mexico

Fähigkeiten und Kenntnisse

pharmaceutical products
New product development
Galenic development
Reformulation of existing products
Evaluation and transfer of production technology a
Optimization and Validation of manufacturing proce
Validation of cleaning processes
Science and Risk-Based Approach for the Delivery o
Systems
and Equipment
manufacturing equipment qualification
desing qualification
installation qualification
operation qualification
performance qualification
critical systems qualification
Design and realization of laboratory and pilot bat
DOE
fabrication of pilot and stability batches
product design
manufacturing process design
development of quality specifications
definition of in-process controls
Design and coordination of stability studies
Elaboration of quality documentation
master formulas
manufacturing instructions
development
qualification and validation documentation
Elaboration of dossiers for registration
application of ICH M4Q
Application of ICH Q8
ICH Q9
ICH Q10
PIC/S GMP guide PE 009-9 and FDA cGMP Guidance for
risk evaluation
risk analysis
risk-based approach for validation
quality by design
experience with health authority GMP audits (Cofep
quality management in the pharmazeutical environme

Werdegang

Berufserfahrung von Robert Sven Jechlitschka

  • Current 8 years and 6 months, since Dec 2017

    Director of Quality Assurance and Development, qualified person

    Schwabe Pharma Mexico

  • 10 years and 2 months, Nov 2007 - Dec 2017

    Head of development & validation / Gerente de desarrollo & validación

    Schwabe México S.A. de C.V.

  • 5 years and 1 month, Aug 2011 - Aug 2016

    Head of development and coordination Schwabe Germany / Mexico

    Dr. Willmar Schwabe GmbH & Co. KG

  • 1 year and 8 months, Apr 2006 - Nov 2007

    Responsible Development & Validation

    Schwabe Mexico

  • 1 year and 4 months, 2005 - Apr 2006

    Apotheker

    Berlin Apotheke

  • 2003 - 2004

    Supervisor de producción

    Schering Mexicana S.A. de C.V.

Ausbildung von Robert Sven Jechlitschka

  • 6 years and 5 months, Oct 1996 - Feb 2003

    Pharmazie

    Freie Universität Berlin

Sprachen

  • German

    C2 (Verhandlungssicher / Muttersprachlich)

  • Spanish

    C1 (Fließend)

  • English

    C1 (Fließend)

  • Russian

    A1-A2 (Grundkenntnisse)

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