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Michel Eyskens

Michel Eyskens

QC Lab manager

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  • Timeline

  • About me

    QA/QC Manager at Cytiva

  • Education

    • HIK Geel Belgium

      1983 - 1986
      Bachelor of Science Uni level 7 Chemistry

  • Experience

    • Janssen Pharmaceuticals

      Jan 1987 - Dec 1997
      QC Lab manager

      International Quality Control of pharmaceutical products from Contract manufacturers and licensee holders. Physical and chemical testing including HPLC, GC, IR and UV.

    • Janssen, Pharmaceutical Companies of Johnson and Johnson

      Jan 1998 - Nov 2004
      IT QA Manager

      Computer Systems Validation to FDA requirements.Implementation (qualification & training) of new computer systems.Develop and maintain documentation (V-model) for LIMS and QMS systems.Write validation protocols, test and implement new systems and software updates.User training and system security management.

    • Douglas Pharmaceuticals Ltd

      Jan 2005 - Sept 2005
      Validation Analyst

      Validation of Manufacturing Processes & Analytical methods. Equipment Qualification.

    • Comvita New Zealand Limited

      Oct 2005 - Feb 2015
      Quality Systems Manager

      QC and release of ingredients, intermediate and finished goods to global markets. Issue management.Chemistry and instument lab management : UPLC, LC-MS/MS and EA/LC-IRMS for analysis of actives, pesticide residues and C4 sugars in honey, propolis and complementary medicines. Compliance with ISO 17025 (IANZ).Shelf life verification.Building & Equipment qualification, Process validation. Keep QC systems compliant with ISO13485, GMP, ISO9001, TGA, HACCP, MPI, UMFHA.

    • Rhondium Ltd

      Mar 2015 - Mar 2016
      QA/QC Operations Manager

      QA/QC management for medical device manufacture of dental devices for global supply.ISO13485 / CFR820 / MDR Cananda

    • Dentsply Sirona

      Apr 2016 - Jul 2017
      QA Specialist

      Maintain and Improve Quality System for Dental Devices manufacturing : Handling of Complaints (Trackwise), Non-Conformance, Deviation, Change Control, Suppliers, CAPA, Documents (SmartSolve), reporting for Management Review & Product Surveillance, Internal Auditing.

    • GE Healthcare

      Aug 2017 - Apr 2020
      QA Leader

      Product Release, Internal Auditing, Document Approval, Customer Audits, Issue Management, CAPA, Non-Conformance, Metrics reporting, CoA generation, Regulatory Audits, Management of Change, Change Control. ISO13485 / ISO9001, ISIA.

    • Cytiva (former GE Healthcare-BioPharma division)

      Apr 2020 - Jan 2024
      QA Leader

      Product Release, Internal Auditing, Document Approval, Customer Audits, Issue Management, CAPA, Non-Conformance, Metrics reporting, CoA generation, Regulatory Audits, Management of Change, Change Control. ISO13485 / ISO9001, ISIA.

    • Cytiva

      Jan 2024 - now
      QA/QC Manager

  • Licenses & Certifications

    • QMS Lead Auditor training ISO13485:2016

      BSI Training Academy
      Mar 2021

    • ISO13485 Clause by Clause training

      BSI Training Academy
      Oct 2020