Quality Representative - Quality Regulatory Compliance (f/m)


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Description

  • Preparation and update of Site Master File
    • Update of Site Master File according to Change Control-system
    • Organization of review & approval for revision of Site Master File at least once a year
    • Organization of current drawings, major equipment catalogue, product flows, etc. for revision of Site Master File
  • Review and approval of AGES-submission dossiers related to manufacturing authorization
  • Tracking of Licensing Commitments
    • Preparation and tracking of action plans for implementation of licensing commitments
  • Coordination of GMP Questionnaires/ Facility Registrations
  • Support for preparation of Product Quality Reviews and Yearly Biologic Product Reports
  • Continous improvement of processes and systems

Qualifications

  • Graduated from a technical, chemical or biological college or university with practical experience of quality operations function or related area
  • Good experience in quality assurance, validation, in depth knowledge of applicable regulations and laws for biological products, such as FDA CFR, cGMP, EU GMP, MD, EU Directives and guidelines as well as understanding of the quality requirements in the area of manufacturing, plant utilities, computer systems and project management
  • At least 2 years practical experience in these fields in a pharmaceutical company
  • Strong communication and technical skills, competence, responsibility, accuracy, reliability, strong analytical skills, good command of English and German, negotiation skills, interpersonal skills, organizational skills, proficient in Microsoft Office WORD/Excel/PowerPoint

This position is limited until End of May 2020.

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. Here you can learn more about Shire in Austria.

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  according to collective agreement for this position is € 3.065,25 gross per month (full-time); increased payment is possible. We are looking forward to your application.

Austria

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