Home Stellen in Singen (Hohentwiel) Takeda GmbH QA Specialist Batch Disposition (f/m/d)

Stellenangebot:
QA Specialist Batch Disposition (f/m/d)

Stellenbeschreibung

Job ID R0021731

Your Accountabilities

  • Compiling all information back to the cell bank for the used Drug Substance (DS) production (4 serotypes) as well as the information for the Drug Product (DP)
  • Implementation of a crossfunctional communication process inbetween the IDT/ VBU and TDV- QA regarding DS/DP production as well as the internal communication paths
  • Implementation of a documentation and archiving system for the relevant data
  • Definition of all country- specific requirements for the disposition process
  • Prepare the documentation for the batch disposition for the QP
  • Ensure all running internal and Vaccine Business Unit (VBU)- relevant change control systems as well as relevant deviations are considered
  • Ensure the consistent communication path inbetween registration dept and TDV- QA
  • Ensure the regulatory compliance of the manufacturing process and analysis
  • Contact person to OMCL (e.g. AGES/ PEI)

Your Profile

  • Bachelor degree in biological or pharmaceutical technology
  • Experience in registration topics/  product disposition/ Compliance as well as with pharmaceutical Quality Operations and production processes
  • Minimum years of  relevant experience: 3 years
  • Good knowledge of EU GMP and FDA regulations
  • Good knowledge in English and German language
  • Solid knowledge in Microsoft Office software
  • Fast understanding of quality situations, and ability to apply knowledge and experience to resolve problems
  • Excellent collaboration and communication skills
  • Ability to work in cross functional and international teams as well as independently
  • Ability to adapt to intercultural differences
  • Pro-active and open mind set, reliable, and self-motivated

Infos zur Stelle
Arbeitszeit:
Vollzeit
Arbeitsort:
Singen (Hohentwiel)
Takeda GmbH
ZUR FIRMENPRÄSENTATION ALLE OFFENEN STELLEN
Kontakt:

Takeda GmbH
Robert-Bosch-Straße 8
78224 Singen

Ansprechpartner:
Selina Wrzeszcz

Tel: 07531 84-5410
germany.jobs@takeda.com
www.takeda.com/de-de