Dr. Oleg Lapochkin

Angestellt, Qualified Person / Head of Quality Control, Catalent Germany Eberbach GmbH (Eberbach, Germany)
Eberbach, Germany

Fähigkeiten und Kenntnisse

Quality Management
QC/QA
Development
Research
Pharmaceutical consulting

Werdegang

Berufserfahrung von Oleg Lapochkin

  • Current 9 years and 5 months, since Jan 2017

    Qualified Person / Head of Quality Control

    Catalent Germany Eberbach GmbH (Eberbach, Germany)

    - classical duties of Head of QC (EU GMP, Clause 2.6) - leading the employees - developing a QA program (Deviation Management Excellence)

  • 3 years and 5 months, Aug 2013 - Dec 2016

    Head of Quality Control

    medipolis Unternehmensgruppe

    Quality Control, QMS, Qualified Person Assistent

  • 9 months, Jul 2012 - Mar 2013

    Qualified Person Assistant

    Klocke Verpackungs-Service GmbH (Weingarten, Germany)

    - batch records review (pre-release), - CoA, CoC review - project leading (process re-validation, equipment qualification, process improvement) - preparing and writing SOPs, Protocols - training employees - recurrent organization of self-inspections and Audits

  • 2 years and 1 month, Apr 2010 - Apr 2012

    QC/QA

    AgenoLAB GmbH & Co. KG (Stuttgart, Germany)

    – planning and carrying out of microbiological and molecular biological analyses - developing a QA program (change control, corrective and preventive actions etc.) as well as GDP (Good Documentation Practice) - administration of the QA program - preparing and writing SOPs, VMP (Validation Master Plan) - training employees - recurrent organization of self-inspections and Audits - preparation of a corrective action plan for observations - formulation of a quality release in the field of documentations

  • 1 year and 7 months, Aug 2008 - Feb 2010

    Project Manager / Service Engineer

    Lumex-Centrum Ltd. (Moscow, Russia)

    – starting-up and adjustment of equipment (fluorometers, HPLC and capillary electrophoresis systems, IR and near IR-spectrometers, AAS etc.) as well as their technical support and maintenance – customer service and consulting – marketing analysis – organization of seminars and symposiums for production advancements

  • 3 years, Sep 2005 - Aug 2008

    Head of Laboratory / Researcher

    Pyatigorsk State Pharmaceutical Academy (Russland)

    – work planning and coordination in laboratory – planning and coordination of validation of analytical methods for pharmaceutical analysis – carrying out of quality control substances, intermediate and finished products under Pharmacopoeias – participation in scientific research studies on various topics – writing scientific articles and reports – participation in regional, interregional, and international conferences

Ausbildung von Oleg Lapochkin

  • 3 years, Sep 2005 - Aug 2008

    Pharmacy: Postgraduate study

    Pyatigorsk State Pharmaceutical Academy

    Thesis “Synthesis and Research Vanadyl Complex Compounds with Amino Acids: Glycine, α-Alanine, β-Alanine“ has been performed and successfully defended. New vanadyl complex compounds have been investigated by different physically-chemical and pharmacological methods.

  • 4 years and 11 months, Sep 2000 - Jul 2005

    Pharmacy

    Pyatigorsk State Pharmaceutical Academy

    The Diploma Qualification “Syntheses and Research of Vanadyl Complex Compound with Glycine”. Awarded the State Fellowship. Graduated with honors.

Sprachen

  • Russian

    C2 (Verhandlungssicher / Muttersprachlich)

  • English

    B1-B2 (Gute Kenntnisse)

  • German

    B1-B2 (Gute Kenntnisse)

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