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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 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

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