Shire Quality Representative (w/m) in Industriestrasse 67 (Baxalta), United States

Responsibilities

  • Subject Matter Expert (SME) for the Change Control Management Systems Vienna

  • Own Change Controls as Change Owner

  • Support the Exception Management System

  • Support Out-Of-Specification (OOS) Events

  • Support the Quality Risk Management System

  • Support Inspections and Audits in respect of Change Control Management System

Key Skills and Competencies

  • Experience with Quality Systems and Change Control Management in a FDA regulated manufacturing setting

  • Thorough knowledge of applicable procedures, specifications, regulations and standards, including ISO 9001, ISO 13485, FDA 21 CFR Parts 210, 211, 600, 820 and International GXPs.

  • Strong analytical and problem solving skills.

  • Strong interpersonal, communication, influencing, and negotiation skills

  • Strong computer skills, excellent writing, organization, and presentation skills.

  • Strong German and English skills in speaking and writing

Company Insights https://youtu.be/ly_8oO-iJeU

Your application should include motivation letter and CV. Remuneration corresponds to the respective classification according to the collective agreement. The minimum salary for this position is € 3,065.25 gross per month (full-time). Increased payment is possible. In addition we offer many social benefits (e.g. canteen, wellness-center, company kindergarten) to mention just a few of them.

We offer outstanding opportunities to committed and talented people. Sex, age, color of skin, origin, ethnicity, sexual orientation as well as a physical handicap do not matter to us. On the contrary: We promote diversity in every field.

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.