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