Oleg Saraev

Bis 2019, Quality Service and Improvement Manager, Takeda Pharmaceuticals
Abschluss: Master degree in Biotechnology, Altay State Technical University
Yaroslavl, Russian Federation

Fähigkeiten und Kenntnisse

EQMS
SAP
Minitab
MS Office
Improvement
Continuous Improvement
Lean
Quality Mindset
CAPEX
Inspection rediness
Trainer
Speaker
Validation
Qualification
Risk Management
Change Control
SME evaluation
Deviation handling
CAPA handling
ISO 9001
GMP
Project management
Operational Excellence
Green Belt
Agile
Change Agent
Quality Expert

Werdegang

Berufserfahrung von Oleg Saraev

  • Current 7 years and 2 months, since Apr 2019

    Change Control Manager

    Takeda in Deutschland

  • 2 years and 10 months, Jun 2016 - Mar 2019

    Quality Service and Improvement Manager

    Takeda Pharmaceuticals

    Improvements coordination and promotion in Quality department; Leading of Quality Mindset improvement; Budgeting of laboratory equipment purchase and process managing till commissioning and qualification; Managing of the tool for Inspection readiness; Provide trainings about Lean basics. Direct report to Site Quality Head.

  • 4 years and 2 months, May 2012 - Jun 2016

    Validation Specialist

    Takeda Pharmaceuticals

    Validation/qualification system management – creation of VMP and quarter/annual reports, creation of validation approach at the plant, review of V/Q documents, batch records and SOPs; Quality Risk Management system coordination – creation of Risk Assessment approach at the plant and RA approval; V/Q and risk management trainings performance; Investigation of deviation in validation/qualification study; Change control subject matter expert evaluation in questions related to validation/qualification.

  • 11 months, Jul 2011 - May 2012

    Validation Engineer

    Altayvitamin

    Validation/qualification activities coordination and clean rooms qualification performance.

  • 1 year and 9 months, Nov 2009 - Jul 2011

    Chemist

    Altayvitamin

    Raw materials and finish products testing.

Ausbildung von Oleg Saraev

  • 4 years and 10 months, Sep 2004 - Jun 2009

    Biotechnology

    Altay State Technical University

Sprachen

  • English

    C1 (Fließend)

  • Russian

    C2 (Verhandlungssicher / Muttersprachlich)

  • German

    A1-A2 (Grundkenntnisse)

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