Shadma Ashraf
Senior Manager-qa @Replimune
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WORK HISTORY
Senior Manager-qa @Replimune
Abingdon-On-Thames, GB
Replimune is a clinical-stage biotech company focused on revolutionizing cancer treatment with a new class of oncolytic immunotherapies intended to activate a powerful and durable full-body anti-tumor response.Responsible for coordination and execution of Quality Assurance systems and processes at Replimune, ensuring their effective development, implementation, and maintenance.
EDUCATION
Centre for Scientific and Industrial Research
Doctor of Philosophy - PhD, Molecular Biology and Genetic Engineering
ISABELLA THOBURN P.G. COLLEGE
Graduation, Science
ABOUT SHADMA ASHRAF
Highly motivated and enthusiastic professional with PhD in life science and extensive experience in Medical devices, IVD, Biotech, and Pharmaceutical industries. A good team player and all-rounder that thrives on challenges and loves multitasking roles. A proven track record of successfully handling several projects of Molecular Diagnostic, Cell-based assays for Drug Discovery and IVD reagents. Skilled in implementing, team building & problem-solving combined with a high degree of Quality and Regulatory awareness.•Proven ability to deliver multiple complex analytical projects to agreed timelines and resources.•Computer System Validation (21 CFR PART 11), Software compliance to IEC 62304 (Software Life Cycle processes). System/Applications validated IFS, ERP SAP, GitHub, SQL, JIRA, Salesforce CRM, Agile, Ensure and CaWeb etc •Considerable experience in Risk Management ISO 14971, GMP, ICH, ISO 13485, 21CFR 820, ISO 9001, ISO 17025, and MDSAP Quality Management system standards. Supplier Qualification and AuditsImplementation of IVDR and MDRAn ambitious individual with the willingness to learn and deliver on commitments, and have a flexible can-do attitude. Seeking a responsible and challenging position in a growth-oriented progressive organization.
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