Marijke Steenvoorde
Head of Quality Assurance at Venn Life Sciences - part of Open Orphan Plc- Claim this Profile
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Nederlands Native or bilingual proficiency
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Engels Full professional proficiency
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Bio
Experience
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Venn Life Sciences - part of hVIVO plc
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United Kingdom
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Research
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1 - 100 Employee
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Head of Quality Assurance
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Oct 2022 - Present
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Quality Assurance Manager
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Oct 2021 - Oct 2022
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Qualitythirst
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Leiden
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Quality Consultant
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Jan 2019 - Present
Quality consultant for organizations in the life science industry in The Netherlands. Management of GCP training, audits and inspections. Creation and implementation of GXP and ISO based quality management systems. Quality consultant for organizations in the life science industry in The Netherlands. Management of GCP training, audits and inspections. Creation and implementation of GXP and ISO based quality management systems.
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Astellas Pharma Europe
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United Kingdom
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Pharmaceutical Manufacturing
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700 & Above Employee
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Quality Assurance Manager
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Apr 2005 - Jun 2018
As Global Quality Lead responsible for identifying, planning, organizing, executing, reporting and follow up of investigator site audits, internal systems audits and vendor audits based upon a risk based approach and trend analysis. Providing expert advice on Good Clinical Practice to colleagues within R&D. Ensuring inspection readiness of departments within R&D and at investigator sites. Extensive experience at managing phase I (1 site, 1 country) to phase IV (435 sites, 42 countries) clinical studies from a GCP QA point of view. Preparing, hosting and following up of inspections by regulatory agencies. Show less
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Various companies, profit and non-profit
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Various locations
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Management support
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Jun 1983 - Mar 2005
More than 20 years of experience in management and office support on various levels in various companies, both profit and non-profit organizations (e.g. law firm, bank, International Red Cross, life sciences). More than 20 years of experience in management and office support on various levels in various companies, both profit and non-profit organizations (e.g. law firm, bank, International Red Cross, life sciences).
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Education
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RQA, DARQA, BTF
Quality Assurance -
SAMI-training
Leiderschap en organisatieontwikkeling -
RQA, DARQA, DIA, on the job
Clinical Quality Assurance -
Dialoog tussen mens en paard