M. Yousffi

M. Yousffi  - Quality Assurance Expert with Extensive GxP Experience (EX FDA)

Mr. Yousffi spearheads crucial quality initiatives and program development, ensuring a data-driven and impactful approach. His leadership guarantees at the forefront of tackling quality challenges. 

Yousffi boasts a distinguished career, holding progressive leadership roles in quality assurance with world-renowned organizations like the FDA, Hospira, Abbott, Fresenius Kabi, AKRON, and Glonal Quality Compliance. With over 18 years spent within the pharmaceutical, biologics, and medical device industries, Yousffi has gained extensive experience in various Good Practice (GxP) disciplines. Their expertise lies in providing proactive, quality-centered auditing, consulting, and training services. 

Education: Mr. Yousffi possesses a strong educational foundation in biochemistry, evidenced by his degrees in the filed of Biochemistry. This background, coupled with his participation in numerous graduate-level workshops and training programs, equips him with a comprehensive understanding of the scientific principles underlying quality assurance practices. 

Demonstrated Expertise:

• Domestic and International GxP Compliance: Yousffi has a proven track record of ensuring adherence to regulatory requirements through auditing across GMP, GCP, GVP, GLP, GDP, and CSV disciplines.

• Diverse Project Scope: Their work encompasses pre-clinical research (GLP), clinical trials (Phases I, II, and III), and commercial manufacturing settings.

• Comprehensive Auditing Skills: Yousffi is well-versed in conducting aseptic/non-aseptic processing audits, co-auditing assessments, and remote/virtual audits.

• Quality Management System (QMS) Development: They possess the ability to develop, assess, and improve QMS for optimal efficiency.

• Streamlined Documentation Management: Yousffi excels at creating SOPs, managing deviations/corrective actions, and ensuring proper documentation practices.

• Regulatory Preparedness: Support for FDA mock inspections and implementation of fraud detection strategies are also part of their skillset.

• Effective Supplier Management: Yousffi's expertise extends to drafting supplier quality agreements and overseeing Contract Manufacturing Organization (CMO) manufacturing processes.

Yousffi leverages their in-depth knowledge and experience to assist clients in achieving operational excellence within the context of quality assurance.Schedule a free Consultation Now.

Key Areas of Proficiency:

• Quality Auditing

• Pharmacovigilance

• Good Clinical Practice (GCP)

• Good Manufacturing Practice (GMP)

• Quality Systems