Regulatory Compliance Specialist (m/f/d) – Maternity Leave Replacement

Job Overview

Header:OctapharmaOctapharma specializes in the development of highly pure pharmaceuticals made of human blood plasma. As part of a family-owned enterprise, Octapharma in Vienna is not only the largest production site, but also a successful research location of the Octapharma Group. Since our company continues to grow, we are looking for a maternity leave replacement (until December 2023):

Regulatory Compliance Specialist (m/f/d) – Maternity Leave Replacement

Location:

Vienna, Austria

Job Level:

Entry-level

Job Category:

Quality

Employment Type:

Temporary position

 

 

Your new challenges which will inspire you:

  • Processing & tracking supplier data in electronic reporting systems: (e.g. Supplier – updates, changes, contracts, license status, and audit information)
  • Routine actualization of our supplier database for regulatory submissions, including:
    • updating user requirements
    • participating in validation activities
    • review of current EMA guidelines/requirements
    • confirming supplier information is accurate
    • data entry and preparation for (Plasma Master File) regulatory submissions
    • trending and assessment of supplier data
  • Providing information about our suppliers for regulatory responses, internal inspections
  • Regular interaction with our external suppliers, internal departments, and global subsidiaries

Your profile that will convince us:

  • High school Diploma or comparable education (HAK, HTL,..)
  • Work experience in Quality Assurance or Regulatory Affairs is a plus
  • Advanced knowledge of written and spoken English is a must
  • Profound skills in Microsoft Office (Word, Excel, Power Point) is essential
  • Experience with TrackWise QMS software beneficial
  • Team oriented but able to work independently
  • Excellent organizational and time management skills
  • Ability to multitask with a high level of flexibility

Our attractive benefits for you:

  • Wide range of tasks in an international setting, flexibility and personal responsibility
  • Reliable employer with generous employee benefits and a salary customary in the market
  • Familiar setting of a family-owned enterprise with benefits such as Do & Co staff restaurant, extraordinary staff events and many more:

Additional Information:

The minimum gross wage according to the collective agreement (chemical industry) for your new job is EUR 2.696,88. We strive to adapt your salary to your range of tasks and to your profile, which is why we are ready to pay wages higher than collectively agreed.

We are looking forward to new, committed employees who join forces with us to promote our strong growth in order to keep enabling our patients to live a better life – because it is in our blood! Is it in your blood too?

We are looking forward to receiving your application via our online career portal.

Your contact:

Mag. (FH) Charlotte Ponzer
Octapharma Pharmazeutika Produktionsges.m.b.H.
Oberlaaer Straße 235, 1100 Wien,
T: +43 (1) 610 32 – 1301

 

About Octapharma

As a family-owned company, Octapharma believes in investing to make a difference in people’s lives and has been doing so since 1983; because it’s in our blood. Our company values Ownership, Integrity, Leadership, Sustainability and Entrepreneurship guide us in everything we do. In 2020, the Group achieved €2.4 billion in revenue and an operating income of €451 million. Octapharma employs nearly 10,000 people worldwide, of which around 1,250 are based in Vienna. We help patients in over 118 countries with products across three therapeutic areas: Haematology (coagulation disorders), Immunotherapy (immune disorders) and Critical Care. Octapharma owns six state-of-the-art Production facilities in Austria, France, Germany (Dessau & Springe), Mexico and Sweden.

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