Summary
Overview
Work History
Education
Skills
Personal Information
Software
Timeline
Generic
Senayit Gebrekidan

Senayit Gebrekidan

Quality Management Professional
Frankfurt/Main

Summary

I have several years of experience in quality management in the pharmaceutical environment. From the management of a production plant to the digitalization of processes. Through my work in consulting, I have a quick understanding and try to find efficient solutions.

Overview

8
8
years of professional experience
27
27
years of post-secondary education
3
3
Languages

Work History

Quality Control Manager, Incoming Goods

Biontech SE
04.2024 - Current
  • Coordination of deviations, CAPAs and CCs
  • Performing of material qualifications
  • Project coordination: Implementing of LIMS to digitalize material releases


Quality Control Manager, Incoming Goods

Biontech SE
04.2024 - Current
  • Coordination of deviations, CAPAs and CCs
  • Performing of material qualifications
  • Project coordination: Implementing of LIMS to digitalize material releases
  • Computer system validation

Sabbatical

10.2023 - 03.2024
  • Travelling through Ghana and Senegal
  • Volunteering in education

Project engineer

Agap2
11.2020 - 09.2023
  • Operational consulting in pharmaceutical companies
  • Focus: Quality Management

Quality Control Engineer

Biotest AG
05.2023 - 07.2023
  • SAP project: Analyzing and finding solutions to interface problems between software and laboratory equipment

Quality Assurance Manager

Sanofi
06.2021 - 11.2022
  • Management of a production plant
  • Release of intermediate pharmaceutical products
  • Coordination of deviations, CCs and CAPAs
  • Drafting, approval and review of quality relevant documents
  • Qualification and validation of processes and materials

Quality Assurance IT Manager

Roche Diagnostics GmbH
12.2020 - 05.2021
  • Documented review of templates according to the ALCOA principle
  • Evaluation of new tools for process visualisation and analysis
  • Qualification of method execution in LIMS

Master's Student

University Medical Centre Mainz
11.2018 - 09.2019
  • Master thesis in the speciality "Radiotherapy and Radiation Oncology"
  • Publication: Zahnreich S, Gebrekidan S, Multhoff G et al., Oxygen Deprivation Modulates EGFR and PD-L1 in Squamous Cell Carcinomas of the Head and Neck. Front. Oncol. 2021 Feb 26

Working Student

Merck KGaA
04.2018 - 11.2018

Department: Classification of hazardous substances

  • Creation, review and updating of safety sheets according to REACH & CLP regulation
  • Database maintenance in SAP EH&S

Bachelor's Student

Immundiagnostik AG
10.2016 - 07.2017
  • Bachelor thesis in protein analytics
  • Mass spectrometric protein analysis via LC-MS/MS
  • Validation and quality control of immunoassays
  • Creation of SOPs

Education

Course - Regulatory Affairs

College of Medicine And Dentistry
Birmingham
04.2001 - 09.2023

Master of Engineering - Biotechnology

University of Applied Sciences
Darmstadt, Germany
10.2017 - 12.2019

Bachelor of Science - Biotechnology

University of Applied Sciences
10.2014 - 09.2017

Skills

Regulatory Affairs (FDA, EMA)

GMP/cGMP - Regulation

REACH- / CLP – Regulation

IVD-/MPG-/AMG - Guideline

Project- and process management

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Personal Information

  • Date of Birth: 09/09/92
  • Nationality: German

Software

LIMS

SAP

Timeline

Quality Control Manager, Incoming Goods

Biontech SE
04.2024 - Current

Quality Control Manager, Incoming Goods

Biontech SE
04.2024 - Current

Sabbatical

10.2023 - 03.2024

Quality Control Engineer

Biotest AG
05.2023 - 07.2023

Quality Assurance Manager

Sanofi
06.2021 - 11.2022

Quality Assurance IT Manager

Roche Diagnostics GmbH
12.2020 - 05.2021

Project engineer

Agap2
11.2020 - 09.2023

Master's Student

University Medical Centre Mainz
11.2018 - 09.2019

Working Student

Merck KGaA
04.2018 - 11.2018

Master of Engineering - Biotechnology

University of Applied Sciences
10.2017 - 12.2019

Bachelor's Student

Immundiagnostik AG
10.2016 - 07.2017

Bachelor of Science - Biotechnology

University of Applied Sciences
10.2014 - 09.2017

Course - Regulatory Affairs

College of Medicine And Dentistry
04.2001 - 09.2023
Senayit GebrekidanQuality Management Professional