Corporate eQMS Administrator (m/f/d)

Corporate eQMS Administrator (m/f/d)

Job-ID: 51200
Location: Wien, AT
Job Level: Professionals
Department: Quality
Working time: Permanent position, Full-time (38 hours)

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:

* Responsible for maintaining the eQMS system and performing tasks related to continuous improvement of this electronic QMS system
* Following up on support issues proactively to provide timely updates and resolutions to end users
* Provide quality oversight and compliance support to implement and validate electronic systems in accordance with the corporate computer system validation procedures and requirements
* Participate in the development and harmonization work of the Pharmaceutical Quality System at Octapharma Corporation
* Develop and maintain eQMS installation and configuration management procedures
* Provide troubleshooting expertise to end users on an ad hoc basis, consulting with the software vendor(s) as needed. Work with the vendor to troubleshoot and resolve application issues. Coordinate and communicate with impacted stakeholders as needed
* Develop or review protocol, plans, scripts, reports, SOPs etc. associated with the implementation and maintenance of eQMS
* Issue change controls to validated state of system through the change control process and participate in planning and implementing changes

Your profile that will convince us:

* University degree or college graduation in life sciences or information technology
* At least 5 years of experience in the Pharmaceutical Industry preferably in a FDA regulated environment
* Documented training in GMP, must have working knowledge of FDA (21CFR 210, 211) and EU regulatory requirements
* Very good communication skills in English
* Experience with Trackwise is a plus
* Very good planning and organizational skills and the ability to meet deadlines is required
* Good communication skills when interaction with internal and external stakeholders in a multinational environment

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 salaries higher than collectively agreed.

Your contact:

Marina Ibrahim, M.A.
Octapharma Pharmazeutika Produktionsges.m.b.H.
Oberlaaer Straße 235, 1100 Wien
T: +43 (1) 610 32 - 1308

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 around 10,000 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 180 plasma donation centers across Europe and the US.

Fore more information, please visit www.octapharma.com.