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. • Support Regulatory Inspection readiness initiatives and activities across different disciplines.• Conduct gap assessments on standards and work with the individual departments to complete them. • EU MDR Gap Assessment and Implementation Core Team Member• Achievements include:o Gap Assessment and Implementation of MDSAP ISO 13485:2016 regulatory and quality standard, which resulted in the certification of the site.o Recognition Award for contributing to the success of Notified Body inspections which resulted in 0 NCs.

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, established standards, agency regulations, guidelines, and industry compliance trends.• 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), IRB (as required).• 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 corrective actions), customer complaint trending and resolution, facility finished product photo standards, Infinity QS plant statistical process control success, CSD (Continuous Skills Development), pillar contributing member and liaison with Food Safety and Quality pillar.

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 with levels of customer’s requirements and Biotron’s requirements set in our Quality Objectives. (Product Release)- Record finished or returned product nonconformities on Nonconforming product log.- Participating in Kosher/Halal site audits.- Making adjustments as requested.- Requesting Certificates of Free sale from USDA and State of Utah. Maintaining records.Control of Records and responsibilities:- Monthly review of cleaning, maintenance, equipment and other logs and records.- Manages change control to controlled documents.- Preparation of Standard Operating Procedure Documents and other controlled documents such as equipment maintenance logs, cleaning logs etc.Corrective and Preventative Actions:- Understanding the processes and procedures for Corrective and Preventative actions- Initiation of CAR/PAR- Review and approve documentation for Vendor Qualifications, R & D Tracking, HACCP, In house tests such as particle size, bulk density, etc.- Create and maintain cleaning procedures for all equipment. Create and audit cleaning logs (monthly).- Maintain files for all MSDS sheets. (Both Biotron and Suppliers)- Maintain files for Specification sheets and the variations of spec sheets.- Regulatory compliance (FDA, Dept. of Agriculture, US DOT, etc.)- Gather samples for customer requests and pulling together relevant information.- Creates labels for products sent for testing and samples sent to customers.- Completes raw materials projections.- Supervise QC Assistant.- Rationalize nomenclature system and catalog on spreadsheet with:o Allergen statementso Product document folders

• 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