Qualification / Validation Expert (m/f)

Octapharma Pharmazeutika Produktionsges.m.b.H.
  • Wien
  • Vollzeit
  • Berufserfahrung
  • 15.11.2017

As an international family business of manufacturing Human proteins we are proud of this: our products save lives. We have strong European roots and are growing continuously.
Therefore, we are looking for a

Qualification / Validation Expert (m/f)

Corporate Operation Support

Your tasks are diverse - from Support during Basic and Detailed Design of new manufacturing facilities to PerformanceQualification as contact partner for our contractors for major international projects. This includes:

  • Develop Validation Master Plan for contractor
  • Coordinate Risk Assessment for defined scope of Validation Master Plan
  • Support and review of technical documents such as URS (User Requirement Specification)
  • Coordinate and document Design Qualification
  • Support generation and review of protocols and reports for IQ, OQ and PQ
  • Lead qualification/validation activities in the course of major international projects and establish traceability matrix for major qualification/validation projects
  • Perform and review local qualification activities

What we expect?

  • Completed University degree in Technical Science or Biotechnology
  • At least 5 years of working experience as an Expert / Consultant in Pharma or other strongly regulated business
  • Fluency in English is a must, Russian would be of an advantage
  • Very good communication and presentation skills
  • Self-starter, hands on mentality
  • Engaged and motivated
  • Willingness to travel up to 50%

What we offer?

  • Versatile tasks in an international environment, flexibility and self-responsibility
  • Familiar surroundings of a family business with benefits such as Do & Co company restaurant and exceptional employee events
  • Reliable employer with generous social benefits and marketable payment. The basis for this position: Collective agreement for employees of the chemical industry VG IV

Do you want to become a member of the Octafamily? We look forward to receiving your application:

Appy now

Pharmazeutika Produktionsges.m.b.H.
Oberlaaer Straße 235, 1100 Vienna, Mag. Werner Mikschicek
T: +43 (1) 610 32 - 1303, www.octapharma.com

Key facts about Octapharma Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein products manufacturers in the world and has been committed to patient care and medical innovation since 1983. Its core business is the development and production of human proteins from human plasma and human cell-lines. Octapharma employs approximately 7,200 people worldwide to support the treatment of patients in over 100 countries with products across the following therapeutic areas: Haematology (coagulation disorders), Immunotherapy (immune disorders), Ciritical Care. Octapharma owns five state-of-the-art production facilities in Austria, France, Germany, Sweden and Mexico. For more information visit www.octapharma.at

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Über uns

Als internationales Familienunternehmen der Humanproteinverarbeitung haben wir uns seit 1983 der Patientensorgfalt verschrieben und sind stolz darauf: Unsere Produkte können Leben retten. Wir sind in über 100 Ländern weltweit mit Produkten aus folgenden Therapiegebieten präsent: Hämatologie…

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