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GMP Specialist/Expert (m/f)


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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

As this is a maternity leave replacement, the role is limited until September, 2019. Internal applicants with a permanent contract will be placed in the role for a limited time, but your contract will remain permanent.

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.

Austria

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