Faiz Khan
Angestellt, Associate Director Clinical QA, Manager GCP QA, MorphoSys AG
München, Deutschland
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I have several years of experience in leading and conducting audits for clinical trials in oncology and other therapeutic areas. I am an experienced auditor in GCP, GCLP, and GLP, and I have a deep understanding of international regulations, ISO standards, and inspection readiness. My core competencies include developing and implementing risk-based audit strategies, managing cross-functional teams, acting as a GCP expert for ongoing projects, and ensuring quality and compliance throughout the clinical development process. I collaborate with various stakeholders, such as clinical operations (CTT), medical affairs, data management, and suppliers. I have a proven track record in delivering high-quality audits for CROs, TMFs, CSVs, data integrity, investigator sites, systems, and suppliers, covering Phase I-IV trials. My mission is to support MorphoSys in developing and delivering innovative and effective oncology treatments for patients.
Werdegang
Berufserfahrung von Faiz Khan
Bis heute 1 Jahr und 10 Monate, seit Aug. 2022
Associate Director Clinical QA, Manager GCP QA
MorphoSys AGThe role involves leading GCP projects, implementing risk-based audit strategies, and developing Quality Management documents. As a GCP expert, responsibilities include planning and conducting audits, collaborating with consultants, and guiding cross-functional teams.
Conduct Good Clinical Practice (GCP) audits, Including Contract Research Organizations (CRO) Qualification, Trial Master Files (TMF) audit, Computer system validation (CSV) audit, data integrity, Investigator site audit etc.
1 Jahr und 7 Monate, Nov. 2014 - Mai 2016
Technical Training Manager
julphar
2 Jahre, Apr. 2012 - März 2014
Quality Control Analyst
Cipla Ltd
Sprachen
Englisch
Fließend
Deutsch
Grundlagen
hindi
Muttersprache