Ahmad Al-Hourani, Msc, Pmp, Cqa Email & Phone Number

San Francisco Bay Area, CA, US

• Developed LabWare LIMS Basic scripts to automate LabWare activities.
• Troubleshot and resolved LabWare tickets and issues.
• Working on LabWare LIMS implementation and improvement projects.

Vancouver, British Columbia, Canada

Coquitlam, British Columbia, Canada

Jordan

• Created a complete quality system from the ground up for a new in vitro medical diagnostics plant. The quality system complies with FDA, GMP, and ISO 13485 requirements.
• Created the quality manual and site master file.
• Created the SOPs for FDA six systems for the plant: materials system, production system, packaging and labeling system, Quality system, facilities and equipment system, and laboratory controls system.
• Trained all related personnel on all the SOPs created.

Jordan

• Supervised validation team through day-to-day tasks.
• Created the requalification program, adopting FMEA risk assessment methodology implementation to over 200 machines, creating the requalification procedure and schedule.
• Supervised and conducted validation for plants renovation projects, BMS, HVAC, purified water, and compressed air utilities projects for sterile and non-sterile areas.
• Co-designed and tested SAP process to achieve paperless validation change controls.
• Audited the validation of the corporate-wide DMS and ERP software packages.
• Led validation activities through the project for serialization of products.

Jordan

1. Equipment qualification (IQ, OQ and PQ) and re-qualification.2. Equipment change controls.3. HVAC, BMS, water treatment and industrial steam systems validation.4. Creation and modification of validation master plans (VMP).5. Tracking of machines changes on SAP ERP system.6. Department process improvement projects including central database and archive.

Master'S Degree, Computer And Networks Engineering, Very Good

Bachelor'S Degree, Electrical Engineering, Good