Clara Moura
Engineer Validation Digital Systems @BioNTech SE
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WORK HISTORY
Engineer Validation Digital Systems @BioNTech SE
Mainz, DE
EDUCATION
Escola Politécnica da USP
Quality Management and Engineering
Universidade Federal de Minas Gerais
Pharmacy
ABOUT CLARA MOURA
Bringing a wealth of expertise in Computerized System Validation (CSV) within the pharmaceutical sector, my career is anchored in a profound comprehension of pivotal regulations and guidelines. This encompasses the Good Automated Manufacturing Practice (GAMP5) from the International Society for Pharmaceutical Engineering (ISPE), FDA\'s 21 CFR Part 11, EMA\'s Annex 11, and other critical standards. Seeking to expand my global perspective and expertise, I embarked on a professional journey to Germany. This move has been instrumental in broadening my knowledge base and honing my skills in the CSV domain, positioning me at the forefront of industry innovations and best practices. My proficiency encompasses the entire spectrum of CSV lifecycle deliverables— initial validation plan, requirement specifications, risk assessments, installation, operational, and performance qualifications, traceability matrix and final validation report. I am driven by an insatiable quest for professional growth and learning, and I\'m passionate about fostering quality assurance and upholding data integrity. Keywords: Validation, GAMP5, Computerized Systems Validation, Spreadsheet Validation, Data Integrity, GxP, CFR 21 Part 11, Annex 11, Quality Assurance.
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