Technology Development Quality Lead - Holzkirchen, Deutschland - GULP Information Services GmbH

Lena Wagner

Geschrieben von:

Lena Wagner

beBee Recruiter


Beschreibung

Das dürfen Sie erwarten:


  • Option of permanent employment with our business partner
  • Extensive social benefits, incl. Christmas and holiday bonuses
  • Up to 30 days vacation per year

Ihre Aufgaben:


  • Ensuring that the data required to effectively manage the quality systems is centralized and secure covering all areas of QA
  • Enhancing the business and QA user perspective of the quality system management and general Global Quality Assurance experience e.g. improved web page interactivity, live data updates, landing page for Global Development Quality and subfunctions
  • Removing the need for excel documents to support system maintenance, where possible leveraging system live data e.g. KQI Metrics, Business user management, SOP tools, training curricula, Procedural Boards, Training effectiveness tools, Distribution lists
  • Implementation of lean principles and solutions for data and digital management of the QMS

Unsere Anforderungen:


  • Strong Data Management skills
  • Several years of experience within the pharmaceutical industry e.g. in Pharmaceutical Development and/or Quality Assurance
  • Knowledge of Quality Management Systems generally
  • Knowledge of GMP regulatory requirements and latest trends
  • Familiar with ICH guidelines (e.g. ICH Q7, Q8, Q9 and Q10), FDAregulations (21CFR , Part 4) and EUregulations
  • Experienced in Quality Systems and Data Management with the ability to use and leverage e.g. MS SharePoint, Power Automate, Sway, Excel and PowerPoint
  • Curious, agile and performance driven mindset
  • Collaborative cross functional team player with business results mindset
  • Experienced in working in an intercultural environment

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