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Experiences

Current Experience

  • Senior Manager Contract Operations Quality Assurance
    Since October 2014
    Operational Contractor Quality Management Pharma: * Quality and Technical Agreement update/revision * Deviation support and approval * Change control/support PCR process * Lot disposition level assignment * Batch documentation review and disposition * Quality oversight and primary contact with CMO * Commitment management * Risk management, COQA quality risk dashboard * Non-routine and expedited complaints, trends and alerts * Ad hoc Site Quality Review Team meeting * Notification to management and Area quality review team meeting executive summary preparation * Transfer of contractor management quality oversight between Contractor Quality Leads * Issue quarantine alert notice * Material certification (BSE/TSE, GMO etc.) * Inspection management support (BOH, corporate audit) * PPRs (APR, PQR) * Virtual site overview team * Identify and manage exit strategies

Past Experience

  • Affiliate Quality Operations Lead / Responsible Person for Quality
    December 2013 --- October 2014

  • PQCO Lead / QP
    December 2010 --- October 2014
    Responsible Person for quality in Pfizer Country Office: quality management system, third party oversight, complaint handling, inspection readiness, deviation handling...

  • QA Manager / QP
    October 2004 --- November 2010
    Responsible Person for quality within a GDP environment: * Inspection readiness - own warehouse and outsourced warehouse * Continuous improvement and implementation of the local quality management system (complaint handling, deviation handling, change control, self inspection,...) * SOP management for QA, RA and logistics * Training for quality and logistics * Quality logistics throughout the distribution chain * Third party management: qualification, audit, quality agreement * Projects as warehouse transfer, SAP implementation, Risk Management, Sample Management, Validation of small projects * Artwork approval * Repackaging and relabeling (QP) * Batch specific variations * Technical Terms of Supply * Fost Plus and Vali-Pack declarations * Registered Technical Details Verification * Team management * Including responsibility being also RP for Viiv Healthcare * Stiefel responsibilities (cosmetics)

  • Regulatory Affairs Associate
    May 2003 --- October 2004
    Partly working on regulatory and partly as GDP pharmacist: * Registered Technical Details verification * TSE/BSE database * Analytical variation submissions * Project: new clinical trial legislation implementation + submission of clinical trials * GDP pharmacist: T° monitoring of warehouse + calibration follow-up, SOP management (QA, RA, logistics), training QA + logistics, repackaging and relabeling operation coördination

Personality

Self Assessment :
Analytical thinkingAttention to detailFlexibilityProblem solvingResult OrientedResponsibilityIndependenceCuriosityAdaptability

Knowledge

Self Assessment :
ApplicationsAuditingCAPAcGMPChange ControlChange ManagementChemistry, Manufacturing, and Controls (CMC)Compliance with regulationsContinuous ImprovementCurrent Good Manufacturing Practice (CGMP)Drug regulatory authorities
LinkedIn Assessment :
Regulatory affairsProduct QualityGDPGXPQuality SystemPharmaceutical IndustryCAPAGMP

Education

  • Advanced Master in Industrial Pharmacy (QP) from VUB in 2002
  • industrial pharmacist in Pharmacy from Vrije Universiteit Brussel in 2002
  • in from Regina Caelilyceum - Dilbeek in 1995

Languages

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

Area / Region

Tessenderlo, Belgium

Others

Driving License
  • No