Robert Neijzen

Associate Dir QA, Qualified Person at Organon Benelux
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Contact Information
us****@****om
(386) 825-5501
Location
Utrecht, Utrecht, Netherlands, NL
Languages
  • English Full professional proficiency
  • Spanish Limited working proficiency
  • Dutch Native or bilingual proficiency
  • German Full professional proficiency

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Experience

    • Netherlands
    • Pharmaceutical Manufacturing
    • 200 - 300 Employee
    • Associate Dir QA, Qualified Person
      • Sep 2020 - Present

    • Netherlands
    • Pharmaceutical Manufacturing
    • 100 - 200 Employee
    • Senior Quality Assurance Pharmaceutical Specialist
      • Nov 2018 - Oct 2020

      Senior QA Pharmaceutical Specialist Main activities: - project management: QA/production responsible for construction a new production unit for (1) steriles and (2) semi-solids compounding - Development of QMS, QA policies - Process and cleaning development and validation - Environmental monitoring - Quality risk management - Equipment qualification - Quality Release Senior QA Pharmaceutical Specialist Main activities: - project management: QA/production responsible for construction a new production unit for (1) steriles and (2) semi-solids compounding - Development of QMS, QA policies - Process and cleaning development and validation - Environmental monitoring - Quality risk management - Equipment qualification - Quality Release

    • United States
    • Pharmaceutical Manufacturing
    • 700 & Above Employee
    • Senior Pharmaceutical Specialist
      • Aug 2017 - Nov 2018

      Senior QA Pharmaceutical Specialist in the department of Solids and Packaging. Main responsibilities/activities: - Overall Quality Assurance, working strongly together with the QA department - Various QRM projects e.g. cross-contamination and mix-ups - Production line relocation project. Senior QA Pharmaceutical Specialist in the department of Solids and Packaging. Main responsibilities/activities: - Overall Quality Assurance, working strongly together with the QA department - Various QRM projects e.g. cross-contamination and mix-ups - Production line relocation project.

    • Netherlands
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Manager non-sterile production, packaging, and drug development
      • Mar 2013 - Aug 2017

      Manager and production pharmacist for non-sterile production, packaging, and product development in a fast-growing pharmaceutical company. Main responsibilities/activities: - Managing the production of over 250 different stock products and a >50% growth - Managing 25 employees - Successful introduction of GMP to the production unit. Achievement of GMP status in 2014 - Managing the development and introduction of over 50 new products - QA/QP activities: implementation of QRM, life-cycle approach, deviation, CAPA and change management. - batch release pharmacist and Deputy QP for steriles. - Development of process- and cleaning validation protocols - Introduction and qualification of various new production equipment including a new blister line and capsule production unit - Management of product dossiers Show less

    • Spectator Sports
    • 1 - 100 Employee
    • Sports instructor
      • Jan 2011 - May 2014

    • Netherlands
    • Hospitals and Health Care
    • 700 & Above Employee
    • Hospital Pharmacist
      • Jan 2012 - May 2013

      Pharmacotherapeutic counseling and policy, including therapeutic drug monitoring. Pharmaceutical preparation and QC/QP activities, for example the coordination of stability drug testing for standard preparations, and batch release. In addition, involvement in drug (formulation) development projects. Also, the preparation, execution and coordination of pre-clinical and clinical research. Futhermore, coordination of quality documentation for the purpose of JCI-accreditation of the hospital. Show less

    • Netherlands
    • Hospitals and Health Care
    • 700 & Above Employee
    • Pharmacist
      • Jun 2011 - Dec 2011

      Mainly pharmacotherapeutic counseling, therapeutic drug monitoring, clinical pharmacy- and pharmaceutical (oncologic) preparation activities. Mainly pharmacotherapeutic counseling, therapeutic drug monitoring, clinical pharmacy- and pharmaceutical (oncologic) preparation activities.

    • Netherlands
    • Higher Education
    • 700 & Above Employee
    • student
      • 2004 - 2011

    • Netherlands
    • Hospitals and Health Care
    • 700 & Above Employee
    • Intern
      • Oct 2010 - Dec 2010

      During this traineeship I worked in different departments within the Department of Pharmacy of the UMCU, such as Clinical Pharmacy, Laboratory and Preparations. The numerous projects encompassed, amongst others, projects on validation of analytical techniques regarding quantification of drug levels in body fluids, on drug handover (upon patient admission and discharge), on drug accountability and on clinical trial participation. During this traineeship I worked in different departments within the Department of Pharmacy of the UMCU, such as Clinical Pharmacy, Laboratory and Preparations. The numerous projects encompassed, amongst others, projects on validation of analytical techniques regarding quantification of drug levels in body fluids, on drug handover (upon patient admission and discharge), on drug accountability and on clinical trial participation.

    • Researcher
      • Aug 2008 - Aug 2010

      Initially a 6-month research internship in which I performed a preclinical research project to study the tumour effects of a liposomal formulation of irinotecan in a colorectal cancer model, resulting in an extension by contract for a related project as a researcher. The report was awarded the second prize in the Junior Saal van Zwanenbergstichting competition (grade 9/10). Initially a 6-month research internship in which I performed a preclinical research project to study the tumour effects of a liposomal formulation of irinotecan in a colorectal cancer model, resulting in an extension by contract for a related project as a researcher. The report was awarded the second prize in the Junior Saal van Zwanenbergstichting competition (grade 9/10).

Education

  • Universiteit Utrecht / University of Utrecht
    Master, Pharmacy
    2004 - 2011
  • QP course
  • QP course
  • QP course

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