Medhat Ibrahim Email & Phone Number

Houston, TX, US

New Brunswick, New Jersey, US

New Brunswick, New Jersey, US

Amsterdam, Noord-Holland, NL

Waltham, MA, US

New York, New York, US

Raritan, NJ, US

• Plan and schedule internal audit lifecycle
• Review and approve internal and external observation investigations, action plans and effective monitoring plans.
• Ensure all work performed is in compliance with required regulatory standards, conforms to company policies, and SOPs.
• Proactively identifies and recommends opportunities for improvements.
• Represent site compliance in Quality Systems Management reviews
• Lead internal quality systems audits per MDSAP/ISO 13485:2016 and other applicable regulatory and quality standards.

Springville, Utah, US

• Define the requirements and lead employees to the processes used to develop, establish, and maintain quality compliance programs, policies, procedures, and controls to ensure that all products conform to cGMPs.
• Oversee and is directly responsible for the Quality Management System Compliance Program in Utah and Costa Rica regarding 21 CFR part 820, ISO 13485 and ISO 9001
• Process owner for CAPA System, Internal Audits, Customer Feedback, Training, and Document Control.
• Work with the Global Director of Quality Assurance and Regulatory Affairs in planning, developing, improving and running the Global QMS and Corporate level QMS procedure adaptation and use.
• Represent Regulatory (and Regulatory/Quality as assigned) in various reviews as required by the QMS including but not limited to Management Review, Phase Reviews, Change Management/Change Orders, MRB (as necessary).
• Achievements include:o Created and conducted CAPA SME training to Utah and Costa Rica locations.o Created a gap assessment list and transition plan for ISO 13485 2016.

Slough, Berkshire, GB

Jack of all trades.

Oak Brook, Illinois, US

Ensures the overall adherence to the quality standards and works in conjuction with production supervisor to improve process controls and product quality. Responsible for food safety, food quality and food defense. Responsible for facility EMPC program (Environmental Monitoring for Pathogen Control which includes microbiological swabbing, data entry and.

Centerville, UT, US

- Review Vendor Certificate of Analysis.- Determine the status of raw materials and finished product with appropriate green, yellow or red stickers. Approve or reject status.- Review and sign offs for Batch formulation sheets and packaging and shipping verification forms. Also review of “in process” material.- Review of Biotron’s Certificate of Analysis.

• Responsible for the creation, implementation and execution of Action Sales Plan in the MENA region.
• Serves as the primary customer contact for technical and business issues for those accounts and territories assigned.
• Works with trading support team on all technical issues.
• Studies the market to provide focused, well-researched forecasts that will support the company's business planning,
• Helps the company to develop new business strategies, conduct market analysis, and develop new and improved methods for marketing products in the MENA region through various new and traditional media.
• Attends user group meetings and trade exhibitions.

Doctorate Of Business Administration In Quality Systems Management, Quality Systems

Master Of Business Administration (M.B.A.), International Food And Agribusiness

Master Degree, International Food And Agribusiness

Bachelor; Bachelor Of Arts, Education And English Arts; Teaching English