Shire GMP Specialist (m/f) - maternity leave replacement until September, 2019 in Industriestrasse 72 (Baxalta), United States

This position is accountable for the review and raw data checks of reports and plans (feasibility studies, device qualifications, stability, technical and development reports) generated within the Formulation and Process Development department in Vienna.

About the position:

  • Raw data checks of all generated data in the department

  • Review and approval of Development Master Batch records

  • Review and Approval of Method Qualification reports

  • Department training manager and co-ordinator of ISOtrain and SABA systems

  • Documentation management and administration including archiving of electronic and paper copies

  • Organises and presents complex issues and results across functions and externally within area of expertise

  • Fosters collaborative interactions across groups

  • Proactively networks externally in own area of expertise.

  • Documents data accurately and completely as per established company guidelines and SOPs. Writes documents such as reports, protocols, internal presentations that require minimal editing

  • Edits and approves technical documents, such as reports, and protocols, when written by members of the department. Writes technical reports that require minimal edits for submission to regulatory filings

  • Internal auditor for reports and plans including feasibility studies, device qualifications, stability, technical and development reports

Skills you need:

  • University degree in the area of natural sciences or technical education with experience in a similar position

  • Fluent English and German

  • Ability to interact with internal and external team members and customers

  • Effective communication with Manager, Peers and colleagues

  • Good computer skills including Word, Excel, MS Outlook, PowerPoint, Visio

  • High attention to detail and focus

  • Extensive knowledge of administrative procedures, systems and processes

  • Expertise and knowledge of the Quality and GMP compliance of Pharmaceutical Processes and Products

  • Experience gained within the GMP and Quality Control environment

  • Timely responses to all inquiries

Hier bekommen Sie Einblicke https://youtu.be/E5qfDvazd2w

Bitte bewerben Sie sich mit Lebenslauf und Motivationsschreiben. Das Mindestgehalt entspricht der kollektivvertraglichen Einstufung und beträgt € 2.438,75 brutto pro Monat (Vollzeit); Überzahlung ist möglich. Daneben bieten wir vielfältige Sozialleistungen (z.B. Kantine, Wellness-Center, Betriebskindergarten, um nur einige zu nennen).

Engagierten und begabten Menschen bieten wir interessante Chancen. Geschlecht, Alter, Hautfarbe, Herkunft, sexuelle Orientierung und Behinderungen/Beeinträchtigungen spielen dabei keine Rolle, im Gegenteil: wir fördern Vielfalt.

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.