Sofia Fischer-Chait

QA-Manager bei Luye Pharma AG

Greater Munich Metropolitan Area

About

Experience

  • QA-Manager at Luye Pharma AG
    Nov 2016 - Present · 9 yrs 8 mos

    Since December 2018 Core responsible for Quality Agreements with customers, suppliers and contract laboratories. Expert in audits and inspections for Quality Agrements. Till February 2017 GMP-trainer, responsible for planing and conduction of GMP-Trainings, Quality agreements, writing of relevant SOPs, support at audits and inspections, expert in audits and inspection for Quality Agreements and GMP-Training support supplier qualification, further quality projects

  • QA Manager at Acino
    Sep 2012 - Nov 2016 · 4 yrs 3 mos

    GMP-trainer, responsible for planing and conduction of GMP-Trainings, Technical agreements (TAs, writing of relevant SOPS, support at audits and inspections, expert in audits and inspection for TAs and GMP-Training, support supplier qualification, further quality projects

  • QM/ QA Manager at bene Arzneimittel GmbH
    Feb 2012 - Jun 2012 · 5 mos

    Documentation-Management (Archiving, distribution of documents, etc.), Training of pharmaceutical employees, Tracking of variations and deviations, CAPA, Risk management, preparation and update of documents, retrospective analysis of 630 produced batches, selfinspections and audits

  • Pharmaceutical Trainee at Rumford Apotheke
    Jun 2011 - Nov 2011 · 6 mos

    In order to be recognised by the german autorities as a qualified pharmacist.

  • Trainee at Haupt Pharma
    Jun 2009 - May 2011 · 2 yrs

    Trainee/ Haupt Pharma (Wolfratshausen) Traineeship in verschiedenen europäischen Unternehmen der Haupt Gruppe (oftmaliger Standortwechsel inklusive Auslandsaufenthalten): Konfektionierung, Qualitätssicherung (Validierungen, Qualifizierungen), Qualitätskontrolle, Technologie Transfer, Entwicklungsabteilungen (Formulierungsentwicklung), Klinikmusterabteilungen, Produktionsabteilungen, Proposal Management und Customer Service, Durchlauf von Abteilungen im Zentralbereich: Zentralleinkauf, Controlling, Marketing & Competitive Intelegence, Operational Excellence, Rechtsabteilung, Koordination und Beantwortung von RFIs / RFQs, Durchführung von Direct-Marketing-Aktionen