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Summary

inscrit sur la liste des personnes qualifiées, comme prévu par l’article 84 de l’arrêté royal du 14 décembre 2006 concernant les médicaments à usage humain et vétérinaire ainsi que l'article 51 de la directive 2001/83/ce du code communautaire relatif aux médicaments à usage humain, et dans l'article 55 de la directive 2001/82/ce du code communautaire relatif aux médicaments à usage vétérinaire

Experiences

Current Experience

  • Compliance & Validation Support


    Since August 2015
    - Validation - iq/oq protocols review - Coaching for Qualification, capa, ue, Change Control, audits - continuous capas/ue/rpcs follow up and daily extracts - audits and inspections readness and fronting - projects management - Validation - IQ/OQ Protocols review - Coaching for qualification, CAPA, UE, Change Control, Audits - Continuous CAPAs/UE/RPCs Follow up and daily extracts - Audits and Inspections readness and fronting - Projects Management

Past Experience

  • Bulk production operational support

    March 2014 --- July 2015
    bulk production operational support: unplanned Event Management

  • Qualified Person Intership at Baxter Medical Products & Bioscence

    January 2014 --- March 2014
    review of product batch records establishment prodcuct master batch record assessment of product certificate of Analysis for each country according to specific maa’s specification; Analysis and Quality Control: -Analysis of conformity of raw materials according to the pharmacopoeia (ph eur, usp) -Analysis of conformity of finished products according to pharmacopoeia (ph eur, usp)) (clinolipid) -control of medicines in accordance with good Manufacturing practices (cGMP) - oos and oot assessment.

  • Qualified Person internship at CQA BDCE

    September 2013 --- November 2013
    global Quality Assurance, changes control management, handling samples for non human usemedical Medical Devices regulatory regulation requirement and interaction with customer and wholesalers

  • Trainee at Corporate Quality Assurance (CQA) BDCE

    February 2013 --- May 2013
    corporate Quality Control (cqa): implementation of new good distribution practices in the warehouse and current good Manufacturing practices in the repackaging department of the distribution centre europe. assessment of quality Risk Management,

Personality

Self Assessment :
AdaptabilityFlexibilityInterest in knowledgeOptimismProblem solvingPerspective

Knowledge

LinkedIn Assessment :
GMPQuality AssuranceRegulatory affairsPharmacovigilanceCAPAQuality ManagementDeviation ManagementPharmaceutical IndustryQuality Risk ManagementMicrosoft WordQuality ControlPharmaceuticsGood distribution Practices21 CFR Part 11OutlookJMPNon Conformity Request (NCR)Change Control MangementAuditValidationProject Management

Skills and Expertise

Self Assessment :
Aseptic processingCreate SOPsMonitor Key Performance Indicators (KPI's)Quality control processproject managementRelease productsIdentify risksCollaborate with project team

Education

  • Advanced Master in Industrial Pharmacy from Catholic University of Leuven in 2013
  • Certificate in Pharmaceutical industry from Université catholique de Louvain in 2012
  • Doctor of Pharmacy, PharmD, Pharmacy in Pharmaceutical Sciences from Université de Cocody Abidjan in 2010

Languages

BrightOwl Assessment:
Self Assessment:
Afrikaans
Native
French
Native
English
Professional Proficiency

Work Preferences

  • Positions I am interested in:
    Industrial Pharmacist Pharmacist Qualified Person
  • Work From Home:
    No
  • Work Regime:
    Permanent position :    100% FTE
  • International:
    Yes

Area / Region

Bruxelles, Belgium

Others

Driving License
  • Yes

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