Senior Validation Analyst

3 semanas atrás

São Paulo, São Paulo, Brasil Guerbet Tempo inteiro
At Guerbet, we build lasting relationships so that to enable people to live better. This is Our Purpose.
We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional imaging. As a pioneer in the field of contrast products since the last 95 years ,we continuously innovate. We dedicate 10% of our revenue to Research & Development such as to improve the diagnosis, prognosis and quality of life of patients.
Achieve, Cooperate, Care and Innovate are the values that we share and practice on a daily basis.
Working at Guerbet is not only being part of a multicultural team of 2,600 people across more than 20 countries, but, it is above all about playing a unique role in the future of medical imaging.
The Sr. Validation Analyst will actively participate in the Company's Quality System to ensure the achievement of Validation of Computerized Systems to enable compliance with the requirements of ANVISA Resolution - RDC 658, Normative Instructions 43/19 and 138/22 and related International Guides.
YOUR ROLE
- Keep the Computer System Validation Plan updated based on GAMP5 and FDA 21CFR Part11, Data Integrity and Policy;
- Preparation of documentation relating to the Life Cycle of the computerized system, included: Planning, Risk Analysis with the user, Functional Technical Specifications, Risk Analysis, IQ/OQ/PQ Protocols and Forms, Final Report and Periodic Reviews;
- Support CAPA, Deviations and Change Control;
- Contribute to Key Performance Indicators and other area metrics including Compliance, Quality, and Individual Productivity Metrics
- Support Guerbet to be compliant with the requirements of regulatory agencies, such as ANVISA and ANSM.
YOUR BACKGROUND
- Minimum 2 years of experience in Computer System Validation (CSV).
- Minimum bachelor's degree registered Pharmacist, Information Technology, Chemistry or Chemical Engineering.
- Fluency in English is required.
- Safety database and other platforms required, MS Office suite and digital skills.

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