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QC Data Integrity Senior Expert (f/m)

Shire am 16.09.2018 in Wien




QC Data Integrity Senior Expert (f/m)

Job-ID: R0026109
Location: Austria - Wien - Lange Allee 24 (Baxalta)
Category: Quality Control

Tasks:

  • Implementing the Data Integrity 21 CFR Part 11, GAMP 5 and EU GMP-Guideline in the QC labs.
  • Evaluation of Analytical systems regarding Data Integrity requirements of 21 CFR Part 11, GAMP 5  and EU GMP-Guideline.
  • Creation of Data Risk Assessment, Data Integrity Assessment and Data Integrity Quality Risk Assessment.
  • Preparation of Remediation Plan to implement the outstanding points.
  • For whole QC Vienna

Requirements:

  • Education in technical or natural sciences (biotechnology, biochemistry, chemistry or similar)
  • Long-time experience in a QC lab environment
  • Good knowledge about Data Integrity 21 CFR Part 11 , Analytical instrument-Qualification (EU GMP-Guideline, USP Chapter <1058>),Computerized System-Validation (GAMP 5, 21 CFR Part 11) and their Life cycle-Management
  • Good knowledge concerning cGMP, especially Laboratory related topics and about Regulatory requirements concerning Analytical Instruments
  • Good communication, presentation and organizational skills, Target-oriented, Team player
  • Fluency in both German and English (technical writing)

As a leading global biotechnology company we have one mission every day: to lastingly improve the lives of people living with rare diseases. Crucial to our mission are our employees – our biggest asset – who enjoy a range of benefits and career opportunities, such as trainee and training programs, job rotations, apprenticeships, work-life balance (certified family friendly), company kindergarten, wellness center, cafeteria, etc. Here you can learn more about Shire in Austria.

We offer outstanding opportunities to motivated people regardless of your gender, age, skin color, ethnicity, sexual orientation or physical handicaps. Diversity is part of our success!

The minimum salary for this position is € 3.163,33 gross per month (full-time); increased payment is possible. We are looking forward to your application.

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Titel QC Data Integrity Senior Expert (f/m) Dienstort Wien Unternehmen Shire
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Beschäftigungsart Vollzeit Position ohne Personalverantwortung Gehaltsangabe 3.163,00 € /brutto
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