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Computer System Validation Specialist - Corporate Drug Safety (m/f/d)

Job ID:  48621
Location: 

Wien, AT

Job Level:  Entry Level
Job Category:  Drug Safety
Employment Type:  Permanent position
Career Level: 

Octapharma 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 now hiring for our team:

 

Your new challenges which will inspire you:
 

  • Be part of a successful international pharmaceutical company
  • Work in Computer Systems Validation Projects under application of GxP guidelines
  • Work in the area of pharmacovigilance and partner with drug safety specialists
  • Create, execute and/or review IT system qualification and validation related documentation
  • Assess and/or author change control, incidents, deviations and investigations related to computer systems
  • Create or contribute to computer validation related SOPs
  • Participate in software life cycle management 
  • Act as or support system administrator of drug safety IT application(s)
  • Communicate with software suppliers and IT help desk
  • Participate in authority inspections and audits

 

Your profile that will convince us:
 

  • Degree in bioinformatics, computer science or degree with strong IT background or several years of professional experience in a comparable position in the pharmaceutical industry
  • Very good level of computer literacy
  • Deep understanding of relational database management systems and expertise in understanding and creating SQL queries 
  • Knowledge of MS Access and Visual Basic for Application (VBA) is a plus
  • Experience with data reporting and report creation as well as risk evaluation and software testing is a plus
  • Experience in the plasma or pharma industry or any other highly regulated industry as well as GxP related IT projects is a plus 
  • Knowledge of 21CFR part 11, EU-GMP Annex 11 and other regulations is a plus
  • Knowledge of ARISg, LSMV systems is a plus
  • Strong verbal and written communication and documentation skills (English and German)
  • Strong organizational skills
  • High level of accuracy with attention to detail as well as analytical skills
  • Proactive personality with a high degree of accountability
  • Team player

 

 

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 salary according to the collective agreement (chemical industry) for your new job is EUR 3.909,67. 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

Working at Octapharma

Whether your interests lie in the field of research and development, production, marketing, sales, finance or engineering, there are many career opportunities at Octapharma

We are the world's largest family-owned plasma company and entirely European. In the spirit of our founder Wolfgang Marguerre, we do not pursue short-term profit goals, but have future generations in mind. Our vision: we are passionate about developing new healthcare solutions that improve lives. We own 6 modern production facilities in Austria, France, Germany, Sweden and Mexico. The Marguerre family continues to play an essential role in the company's day-to-day operations.

Octapharma wants to offer its employees a working environment that challenges them as much as it enriches them. Since its foundation in 1983, the company has grown steadily and today we employ almost 10,000 people.

If you are interested in becoming a part of Octapharma, we invite you to apply for one of our open positions.

About Octapharma

Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines.

Octapharma employs more than 11,000 people worldwide to support the treatment of patients in 118 countries with products across three therapeutic areas: Hematology, Immunotherapy and Critical Care.

Octapharma has seven R&D sites and five state-of-the-art manufacturing facilities in Austria, France, Germany and Sweden, and operates more than 190 plasma donation centers across Europe and the US.

Fore more information, please visit www.octapharma.com

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