Corporate eQMS Administrator
7 days ago
We are seeking a highly skilled Corporate eQMS Administrator to join our team at Octapharma. As a key member of our quality assurance team, you will be responsible for maintaining our electronic quality management system (eQMS) and ensuring its continuous improvement.
Key Responsibilities- Maintain and improve the eQMS system to ensure compliance with regulatory requirements and corporate standards.
- Provide timely support to end-users, resolving issues and providing updates on system maintenance and upgrades.
- Ensure quality oversight and compliance support for electronic systems, validating them in accordance with corporate procedures and requirements.
- Participate in the development and harmonization of the Pharmaceutical Quality System at Octapharma Corporation.
- Develop and maintain eQMS installation and configuration management procedures.
- Provide troubleshooting expertise to end-users, consulting with software vendors as needed, and coordinating with stakeholders to resolve application issues.
- Develop or review protocols, plans, scripts, reports, SOPs, and other documents associated with eQMS implementation and maintenance.
- Issue change controls to validated state of the system through the change control process and participate in planning and implementing changes.
- 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 and 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, with the ability to meet deadlines.
- Good communication skills when interacting with internal and external stakeholders in a multinational environment.
Octapharma is a leading human protein manufacturer, developing and producing human proteins from human plasma and human cell lines. We employ nearly 12,000 people worldwide to support the treatment of patients in 118 countries with products across three therapeutic areas: Immunotherapy, Haematology, and Critical Care.
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