Global eQMS Solutions Expert
3 days ago
We are seeking a highly skilled Corporate eQMS Administrator to join our team in Vienna, Austria.
About the JobThe ideal candidate will be responsible for maintaining and improving our electronic Quality Management System (eQMS) to ensure compliance with regulatory requirements.
This is an excellent opportunity to work in a dynamic environment where you will have the chance to develop and maintain eQMS installation and configuration management procedures.
You will also provide quality oversight and compliance support to implement and validate electronic systems according to corporate computer system validation procedures and requirements.
Furthermore, you will participate in the development and harmonization of the Pharmaceutical Quality System at Octapharma Corporation.
Responsibilities- Maintain and improve the eQMS system to ensure compliance with regulatory requirements.
- Provide quality oversight and compliance support to implement and validate electronic systems.
- Develop and maintain eQMS installation and configuration management procedures.
- Participate in the development and harmonization of the Pharmaceutical Quality System.
- Responsible for following up on support issues proactively to provide timely updates and resolutions to end users.
- Collaborate with internal and external stakeholders in a multinational environment.
- 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.
- Excellent communication skills in English.
- Experience with Trackwise is a plus.
- Strong planning and organizational skills and the ability to meet deadlines.
- Good communication skills when interacting with internal and external stakeholders.
We offer a competitive salary of EUR 4,157.14, as well as a wide range of tasks in an international setting, flexibility, and personal responsibility.
Our company provides reliable employee benefits, a salary customary in the market, and opportunities for professional growth and development.
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