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Summary

Qualified Person/Sachkundige Person in the Pharmaceutical industry / Quality Assurance Manager - 10+ years’ experience in QA & QC in the pharmaceutical industry, ensuring compliance with cGMP, EEC, ICH, ISO9001 and WHO guidelines - ~3 years’ supporting a portfolio of up to 10 regional and global suppliers, and to include coordinating validation studies and equipment installations and repairs - Achievements include helping a company pass a Ministry of Health GMP audit (2012/13), setting up a QC laboratory and a quality system (2012/13) and facilitating product brand and trademark registration via the Patent Institute in the EU (2013) - Have participated on 2 turn-key projects and have led quality teams of up to 10 and have delivered cGMP training to groups of up to 50 - Hold a B.Sc. in Chemistry (2000), an AA in Business Administration (2014); currently completing M.Sc. in Pharmaceutical Quality Management (University of Vienna, expected 03/2016) - Recently passed exam for the Qualified Person/Sachkundige Person status in the EU (01/2016) - Employers include: Hexal A.G (Germany), Tillomed Laboratories (UK), Osel Pharma, Laurus Pharma

Experiences

Past Experience

  • Qualified Person/Sachkundige Person Certification
    January 2015 --- January 2016
    • Completing post-graduate course in Pharmaceutical Quality Management (expected 03/2016) • Acquired industry best practices in managing product reviews, batch releases, quality investigations, CAPA management, certifying and registering documents, SOP documentation, vendor management and conducting internal/supplier audits

  • QC & Stability Studies Specialist / Qualified Person / QA Manager / Trainer
    October 2004 --- July 2013
    • Held a number of roles in pharmaceutical QA and QC roles within leading Turkish pharmaceutical companies • Initially served as a QC Specialist at Turktıpsan Inc (a manufacturer of IV solutions in PP bags), where conducted QC tests and helped set up a new lab in Austria (2004-2008) • Then held a number of contractual roles involving QA & QC, to include serving as a Qualified Person at Osel Pharma (2009-11), as QA Manager at Laurus Pharma (2011-12) and as Qualified Person & QA Manager at Cetinkaya Pharma (2012-13) (2009-2013) • Managed batch releases, to including quality investigations, deviation reporting and CAPA management and document certification and registration, and supported a portfolio of up to 10-15 vendors • Handled product reviews, complaints and recalls • Managed the SOP documentation system

  • QC & Stability Studies Specialist
    October 2004 --- June 2008
    Manufacturer of parenteral (I.V.) solutions within polypropylene (PP) bags • Performed QC tests of primary and secondary raw materials and routine tests for finished products and verified stability of the product up to shelf life • Regularly liaised with Austrian consultants (setting up of new laboratory)

  • QC Specialist
    November 2003 --- April 2004
    Specialized in the licensing, marketing and supply of generic and branded pharmaceutical products • Performed QC tests of raw materials and finished products

  • Stability Studies Specialist
    January 2001 --- June 2003
    Manufacturer of generic and complex pharmaceutical products and of patent-free drugs; today a generic division of Novartis under the name of Sandoz. • Performed stability tests of R&D products and prepared reports in the central stability lab • Mutated to Munich HQ for a 6-month period (2001-02)

Personality

Self Assessment :
AdaptabilityAttention to detailCharmCommunicativeCoordinationSociabilityReaction to stressOrganization

Knowledge

LinkedIn Assessment :
GMPGLPGDPCTDCAPAQuality SystemQuality AssuranceQuality AuditingPharmaceuticsRegulatory DocumentationValidationPurchasingChange ControlSoftware DocumentationSOPAnalysisAudit ManagementBatch ReleasesCAPA managementcGMP DocumentscGMP TrainingComplianceContinuous ImprovementContract ManufacturingDistribution FunctionsGLP TrainingInternational CommunicationLeadershipOperations ManagementProduct ReviewsProject ManagementQuality of ProductsRecall ManagementSOP Document SystemsSterile Manufacturingsupplier auditsTeam ManagementTrainingVendor Management

Education

  • M.Sc. in Pharmaceutical Quality Management (expected 02/2016) in from University of Vienna in 2016
  • Associate Degree in Business Administration & Management in from Anadolu University in 2014
  • BSc. in Chemistry in from Orta Doğu Teknik Üniversitesi / Middle East Technical University in 2000

Training and Certification

  • Advanced Certificate of Good Clinical Practice Certification
  • Certification as Qualified Person/Sachkundige Person in the EU, exam passed in 01/2016 Certification
  • ISO 900I, ISO 14000, ISO 14001, ISO 1800 Certification
  • OSHA Certificate Certification
  • Regulatory Affairs Specialist Certification

Work Preferences

  • Notice Period:
    1 week
  • Positions I am interested in:
    QP Quality Assurance (QA) Manager QA Lead Qa
  • Locations I am interested in:
    Austria Belgium Denmark England, United Kingdom Germany Ireland Italy Netherlands Spain Sweden Switzerland Turkey
  • Work From Home:
    Yes, 0 to 1 days per week
  • Work Regime:
    Permanent position
  • International:
    Yes

Area / Region

Austria

Others

Driving License
  • Yes