BrightOwl Loader Loading

Experiences

Current Experience

  • QA documentation specialist


    Since February 2011
    ensure that the storage, issuance, control, Training and retrieval of all controlled documents are managed in a manner which meets cGMP requirements. process and control the Documentation for processes, facilities and systems. contribute to project related activities maintain central, controlled supply of controlled documents originating within the company and/or from contract laboratories. review documents to determine distribution requirements and processes distribution requests according to set procedures. require knowledge of company security regulations and procedures. perform Data entry for tracking documents and specimens. issue logbooks, Laboratory notebooks and unique numbers for different types of documents. work with and maintain the company edms. issues Documentation status reports. archiving function: file master documents, protocols, reports, other controlled documents and associated historical data. define a procedure for the preparation, revision, approval and distribution of standard operating procedures. write departmental procedures. plan and coordinate sopbook audits. active role in internal audits check Documentation for correct lay-out, correct templates, correct references and interact with author. application of the Policy on the welfare of the employees and the environment corresponding the attained Education and instructions by i.a. the correct application of work equipment and personal protective equipment, the reporting of incidents and non-compliances and the assistance in the identification of risks and preventive measures give guidance and support to the other qa Documentation specialists (Teamwork). on call support Ensure that the storage, issuance, control, training and retrieval of all controlled documents are managed in a manner which meets cGMP requirements. Process and control the documentation for processes, facilities and systems. Contribute to project related activities Maintain central, controlled supply of controlled documents originating within the company and/or from contract laboratories. Review documents to determine distribution requirements and processes distribution requests according to set procedures. Require knowledge of company security regulations and procedures. Perform data entry for tracking documents and specimens. Issue logbooks, laboratory notebooks and unique numbers for different types of documents. Work with and maintain the company EDMS. Issues documentation status reports. Archiving function: file master documents, protocols, reports, other controlled documents and associated historical data. Define a procedure for the preparation, revision, approval and distribution of standard operating procedures. Write departmental procedures. Plan and coordinate SOPbook audits. Active role in internal audits Check documentation for correct lay-out, correct templates, correct references and interact with author. Application of the policy on the welfare of the employees and the environment corresponding the attained education and instructions by i.a. the correct application of work equipment and personal protective equipment, the reporting of incidents and non-compliances and the assistance in the identification of risks and preventive measures Give guidance and support to the other QA documentation specialists (teamwork). On call support

Past Experience

  • Consultant Pharma Services at Pauwels Consulting

    July 2012 --- August 2012

  • Accounting clerk

    April 2008 --- March 2011

  • Receptionist

    February 2008 --- April 2008

  • Logistics and planning clerk

    July 2007 --- February 2008

  • Commercial clerk / commercieel bediende

    January 2007 --- July 2007

  • Commercial clerk/ commercieel bediende

    May 2006 --- December 2006

  • Administrative / legal clerk

    March 2005 --- April 2006

  • Project administrator / dossierbeheerder

    March 2003 --- March 2005

  • Project administrator / dossierbeheerder

    July 2002 --- February 2003

Personality

Self Assessment :
Attention to detailCollaborationCoordinationEfficiencyFlexibilityIndividualityInterest in knowledge

Knowledge

LinkedIn Assessment :
Microsoft ExcelLivelinkTrackwisePowerPointEnglishOutlook ExpressAS400 AdministrationBriljantCalculoM-SoftExactFrenchGermandutchQuality AssuranceQuality SystemcGMP practicesSAP LogisticsLogisticsLegislationSoftware DocumentationGMPSOPGXPTrainingSOPLife Sciences

Skills and Expertise

Self Assessment :
Assure medical quality Use content management systemsAdministrative supportAnswer, transfer and handle incoming calls as needed.Archive documentationArchive trial documentation and correspondence.Communicate effectively on different company levelsCommunicationDocument employees training requirementsFollow-up of internal auditsFollow up training programsFollow-up of Quality Management System (QMS) processesGeneral office managementManage Quality Management System (QMS) documentationMonitor Key Performance Indicators (KPI's)Office managementReport Key Performance Indicators (KPI's)

Education

  • Bachelor's degree in practice of law from Katholieke Hogeschool Kempen te Geel in 2001
  • Higher secondary education in Economics & Modern Language from Koninklijk Atheneum Mol in 1999

Languages

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

Work Preferences

  • Locations I am interested in:
    Belgium
  • Work From Home:
    Yes, 0 to 5 days per week
  • Work Regime:
    Permanent position
  • International:
    Yes

Area / Region

Belgium

Others

Driving License
  • Yes

Similar Candidates

Other Candidates in Belgium

Other similar Candidates in this location (country / city)

Other Candidates

Most Recent Searches

Most Famous Searches

You might also like