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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 in 0000 Certification
  • Certification as Qualified Person/Sachkundige Person in the EU, exam passed in 01/2016 in 0000 Certification
  • ISO 900I, ISO 14000, ISO 14001, ISO 1800 in 0000 Certification
  • OSHA Certificate in 0000 Certification
  • Regulatory Affairs Specialist in 0000 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

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