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Summary

since 2011 i worked as quality and hse manager at an international biotech company located in belgium, france and the netherlands. my key responsibility was to ensure that Research activities were quality driven and were operating in a safe working environment. • ensuring Compliance to all local environmental, Health and safety regulations by managing all activities relating to Employee safety and facility environment performance for the international locations. monitoring and reporting Compliance with q&ehs policies. • promoting quality achievement and process improvement throughout the organization • defining, gaining agreement for and implementing the strategies, policies, procedures and Planning required to create and maintain a high quality environment. • creating, gaining agreement for and implementing policies, procedures and reporting processes that encourage the creation of a culture that puts Employee safety as the top priority and meets all statutory Health and safety guidelines. • investigating all actual and potential breaches of quality, environmental, Health and safety policies so that corrective or preventative action could be taken. before 2011, i worked for more than 30 years with wide ranging responsibilities with proven track record in drug Research within the Pharmaceutical Industry. professional development • emergency preparedness and response& incident and accident investigation • prevention Advisor (level 3) • j&j’s Leadership, Change Management and Communication workshops • j&j’s environment Health safety o working with: radioactivity en ionizing radiation o working with: Biological agents and transport o regulated compounds o industrial hygiene specialities risk assessments; occupational Health; capa management; quality & Compliance; iso9001

Experiences

Past Experience

  • Quality & Environmental, Health and Safety Manager

    January 2011 --- September 2015
    as ehs manager directed the implementation and maintenance of a comprehensive environmental, Health and safety Compliance system for plant sites in belgium, the netherlands and france. • provided Leadership and eh&s related technical expertise • ensured Compliance to all local environmental, Health and safety • created, gained agreement for and implemented policies, procedures and reporting • encouraged creation of a culture that puts Employee safety as the top priority and meets all statutory Health and safety guidelines. • provided Technical Support and guidance for all biosafety (up to level 3), gmo, radioactivity and environmental permits • reviewed/analyzed accidents, incidents, specific situations and issues, and conducted field audits, reported and managed the corrective actions. • identified and designed ehs Training needs • identified and managed activities for occupational Health (industrial hygiene), psychosocial wellbeing and ergonomics. • coordinated and prepared activities related to regulatory agency inspections • participated in Due Diligence processes related to ehs during company acquisitions and ipo - initial public offering (nasdaq). • managed and shared internal safety committees. as quality & Compliance manager responsible for the implementation of the global R&D quality & Compliance (q&c) Strategy and providing continuous support to the Research stakeholders related to the following areas: • procedural document (procdoc) management • learning management system (lms) • audits / inspections / capa management system

  • Senior Scientist / Data Manager - Department of Enabling Discovery Capabilities

    April 2008 --- July 2010
    • design, development and management of project database/e-rooms for the antiviral and antibacterial projects. • prevention Coordinator for the department of antimicrobial Research: - license holder of all activities with Biological materials in containment use (bsl 1,2 and 3) - developed safety practices and procedure guidelines - active company committee Member “safety & Health” • abcd (advanced Biology & Chemistry Discovery) editorial committee Member overseeing the loading and management of Biological information (protocols and results) into the j&j global data warehouse.

  • Head Screening Team as Senior Scientist - Department of Antimicrobial Research

    January 2001 --- March 2008
    • established novel Drug Discovery screening platform for several Bacteria (gram positives and negative pathogens) that led to the discovery of fatty acid biosynthesis inhibitors. • discovered a novel anti-tuberculosis compound in a screening system. currently in full development for mdr tb patients. • discovered key molecules for clostridium. • prevention Coordinator for the department of antimicrobial Research.

  • Head Screening Team as Scientist - Department of Virology

    January 1988 --- January 2001
    • established novel Drug Discovery antiviral screening platforms targeting Respiratory viruses (human rhino viruses – human influenza viruses – Respiratory syncitium viruses). • discovered novel anti-Respiratory Virus compounds, and contributed to the human Clinical proof of concepts.

  • Lab Technician - Department of Oncology

    September 1979 --- January 1988
    • performed and developed screens for identifying promising inhibitor chemical classes for oncology targets. • developed innovative solutions via Laboratory Automation for oncology In Vitro screens. • contributed to the Discovery of the radio sensitizing effect of the synthetic microtubule inhibitor erbulozole.

Personality

Self Assessment :
CollaborationAnalytical thinkingCoordinationCreative thinkingFlexibilityOrganization

Knowledge

Self Assessment :
Biochemistry Cell biology R&DAnimal ModelsBiological Drug DevelopmentCell biologyCell CultureCAPABiotechnologyData ManagementInfectious diseasesLaboratory ManagementMicrobiologyMicrosoft ExcelMicrosoft OfficePowerPointProject ManagementQuality Assurance (QA)SOPUnderstanding of regulatory guidelinesWriting Study Procedures and SOPs
LinkedIn Assessment :
Drug DiscoveryBiosafetyEHSMicrobiologyOccupational HealthHigh Throughput Screening (HTS)LaboratoryEmergency ManagementIn VitroHazardous Waste ManagementVirologyChemistryClinical DevelopmentBiosafety Management (BSL-3)GMOQuality Management & AuditingISO 9001Risk Assessment & ManagementErgonomicsControlled substancesRadiation SafetyLegal Facility ComplianceSoftware Quality ManagementCAPALife Sciences

Skills and Expertise

Self Assessment :
Create SOPsCollaborate with project teamCollaborate with principal investigatorCreate standard operating procedure (SOP)Confirm protocol complianceCreate SOPsEnsure data consistencyFacilitate sponsor monitoring visitsFollow-up of internal auditsFollow-up of external auditsFollow-up of quality assurance activitiesFollow-up of Quality Management System (QMS) processesImplement Quality Management System (QMS)Labeling compliance with local regulationsMaintain Quality Management System (QMS)Manage Quality Management System (QMS) documentationPrepare external auditsPrepare final reportPrepare internal auditsPrepare regulatory documentsProvide input to process improvement initiativesProvide trainingQuality control processRegulatory documentationRegulatory submissionsReport non-compliance incidentsRespond to audit findingsReview quality control activitiesReview quality policiesSet-up quality policiesSetup of research equipmentShipment of biological specimenSolve problemsTrain on site staffValidate dataVerify dataWriting regulatory documents

Education

  • in from HORITO Turnhout in 1978
  • Chemistry in Chemistry, Biology, Technology, Physics, English from HORITO Turnhout in 1978

Training and Certification

  • Emergency preparedness and response& incident and accident investigation in 2013 Training
  • Preventieadviseur (niveau 3) in 2011 Certification

Languages

BrightOwl Assessment:
Self Assessment:
Dutch
Native
English
Full Proficiency
French
Elementary Proficiency
German
Elementary Proficiency

Work Preferences

  • Positions I am interested in:
    Quality Assurance (QA) Manager Quality manager
  • Locations I am interested in:
    Antwerp, Belgium Ghent, Belgium Hasselt, Belgium Leuven, Belgium Mechelen, Belgium
  • Work From Home:
    No
  • Work Regime:
    Permanent position
  • International:
    No

Area / Region

Merksplas, Belgium

Others

Driving License
  • Yes

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