Sena Gologlu

Bis 2024, Qualitätssicherungsspezialistin, Gensenta Pharmaceuticals
Abschluss: Master, North Dakota State University
Rosdorf, Germany

Skills

MS Office
Team work
Reliability
SAP
Corrective and Preventive Actions
QMEX System
Quality management DIN EN ISO 9001:2015
Corrective and Preventative Actions (CAPA)
Change Control
Internal and External Audits
International Business
Contract Manufacturing
Client Management
English Language
Communication skills
Learning Agility
GMP Compliance
Regulatory Compliance
Quality Management
Responsible
Motivation
Microsoft Excel
ERP
Biologie
Deutsch
ISO
QMS
cGMP manufacturing
EMA Compliance
Abweichungsmanagement
SOP- Erstellung
Inspektionsvorbereitung
Root Cause Analysis
DIN EN ISO 9001

Timeline

Professional experience for Sena Gologlu

  • 1 year and 2 months, Jul 2023 - Aug 2024

    Qualitätssicherungsspezialistin

    Gensenta Pharmaceuticals

    QA‑Spezialistin mit Erfahrung in GMP‑Herstellung. Schnittstelle zu internen QA‑Teams und CMOs; Überwachung aseptischer/nicht‑aseptischer Prozesse inkl. Chargen, Media Fills und Produktionsaufsicht. Leitung von CAPA/Change Control, RCA und SAP‑Batch Release. Erstellung von SOPs, MBRs, Risiko‑/Validierungsdokumenten und Nitrosamin‑Bewertungen. Audit‑/Inspektionsvorbereitung sowie Unterstützung von APQR und kontinuierlicher Systemverbesserung.

Educational background for Sena Gologlu

  • 1 year and 10 months, Aug 2021 - May 2023

    Biomedical Engineering

    North Dakota State University

  • 1 year and 10 months, Aug 2019 - May 2021

    Biology

    University of Southern Mississippi

  • 1 year and 9 months, Oct 2017 - Jun 2019

    Biology

    Middle East Technical University

    Bachelorstudium der Biologie begonnen, im dritten Jahr an die USM transferiert.

Languages

  • Turkish

    C2 (Expert / native speaker)

  • English

    C1 (Fluent)

  • German

    B1-B2 (Good)

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