Jobdetails

2019-01-02 Oversight (maintenance and compliance) of training system and implementation of measures if relevant KPIs are not fulfilled; Interface to global Business
Titel

QA Quality Specialist (m/f)

Dienstort Orth an der Donau Niederösterreich Unternehmen Shire
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Beschäftigungsart Vollzeit Position ohne Personalverantwortung Gehaltsangabe 2.516,80 € /brutto Jetzt online bewerben

QA Quality Specialist (m/f)

Shire am 12.01.2019 in Orth an der Donau



QA Quality Specialist (m/f)

Job-ID: R0030711
Location: Austria - Orth an der Donau (Baxalta)
Category: Quality Documentation

This position has three main functions:

  • Training Management
  • Oversight (maintenance and compliance) of training system and implementation of measures if relevant KPIs are not fulfilled
  • Interface to global Business Process Owner in order to align training requirements
  • Interface to other Takeda sites for exchange on technical or content wise questions and exchange of experience within the Network
  • Training system administrator function on site
  • Participation in regular “Training Site Lead Call”
  • Provide support during external and internal audits regarding Training related topics
  • Processing requested changes to curricula or assignments
  • Partner with Document Authors / Business Process Owners to determine the training approach
  • Develop, approve and control all training materials used to conduct GxP training
  • Manage Trainer Qualification
  • Manage Training Documentation
  • Develop, maintain and manage onboarding and periodic refresher GMP trainings
  • Document Management
  • Oversight (maintenance and compliance) of document management system and implementation of measures if relevant KPIs are not fulfilled
  • Interface to global Business Process Owner in order to align document management system requirements
  • Interface to other Takeda sites for exchange on technical or content wise questions and exchange of experience within the Network
  • Creating and routing of documents through the draft, review and approval process
  • Working with the Document Owner to manage the creation, revision and obsolescence of documents and determine training requirements
  • Change Target Effective Date and Obsolescence Date, Cancel Issued Documents
  • Veeva Administrator function on site (retrieval of documents, change of document owners/document numbers, retrieval of obsolete document, provision of documents,…)
  • Adaption and approval of Document Templates
  • Provide support to internal and external customers (local and global) with regards to all topics linked to documentation (e.g. formatting, re-assignment, technical support on Veeva)
  • Manages reporting (metrics) of documentation activities and takes action if some trend is seen
  • Leads and participates in projects (both local or global) in consolidation of global requirements
  • Benchmarks with other sites to be aligned or to improve the Document Management System
  • Provide support during external and internal audits regarding Document Management related topics
  • Archive responsible person on site
  • Administrative Support for QA department, e.g.
  • Administration of regular Quality Management Review Meetings
  • Administration of inspections & visits (room booking, catering,…)
  • Time Tracking
  • Maintenance of Organizational charts
  • Administration of COUPA
  • Organization of Business Trips
  • Inventory evaluations and assessments


Skills you need:

  • Experience in Document and Training Management Systems
  • Organizational skills
  • Proficiency in MS Office and ability to use electronic systems
  • At least a high school diploma or comparable education
  • Experience in GxP environment highly desired
  • Excellent organizational and interpersonal skills
  • Collaboration, teamwork & integrity
  • Organized and structured work
  • Focused on reaching objectives
  • Proactive and solution oriented
  • Self-motivated and takes personal ownership
  • Fluency in German and English


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.
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 € 2.516,80 gross per month (full-time); increased payment is possible. We are looking forward to your application.

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