IT Compliance Consultant
3 dni temu
Company Overview:
B. Braun Melsungen AG is a future-focused company that aims to improve people's lives worldwide. We're committed to protecting and improving health through innovative products and services.
About the Role:
We're seeking an experienced IT professional to join our IT-Governance Team as an Inhouse Consultant IT Quality Assurance. This role will involve managing qualification and validation activities, ensuring compliance with regulatory requirements.
Key Responsibilities:
- Coordinate qualification and validation activities between IT and business.
- Develop and execute training programs for CSV (Computer System Validation).
- Manage change control processes and maintain qualified status of applications and infrastructure.
- Administer B.DoCS and ensure quality-related documentation is up-to-date.
- Monitor periodic reviews and update document management systems.
Requirements:
- Bachelor's degree in Computer Science or related field or equivalent work experience.
- Knowledge of GxP requirements and standards, i.e. ISO 9001, ISO 13485, 21 CFR 820.
- Excellent CSV and GAMP 5 knowledge.
- Experience with agile development methodologies, SCRUM, KanBan.
- Proficiency in requirement management tools, JIRA, Polarion.
- SAP QM knowledge is beneficial.
- In-depth knowledge of MS Office products, especially Word, Excel, and PowerPoint.
- Experience with cloud platforms and technologies.
- Good verbal and written communication skills in English (C1).
- Ability to work unsupervised in a global team environment.
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