Karim Salem

QHSEMS, HACCP, FSMS, FSSC, BRCGS & Medical device Lead Auditor and Tutor BRCGS Approved Training Partner

Sector: Food Sector Scope: Bakery & Pastry Achievement: - Preparation and Successful certification for ISO9001, FSSC 22000 manufacturing and BRC (Grade A certification has been achieved) - Lead food safety team. - Conduct the internal and supplier audits. - Supervised validation: product & process. - Supervised calibration process. - Manage DC, QC & QA departments.

Medical Device Auditor - I have conducted around 53 audits man-days, EA scope (4, 12, 13, 14) QMS Auditor - I have conducted around 22 audits man-days, EA scope (3, 13)

Medical Device - I have prepared about 20 companies for ISO 13485 and about 24 technical files according to MDD 93/42/EEC. I have conducted validation/ qualification for ETO sterilizer, clean room. Food Sector - I have prepared about 7 companies for BRC and grad (A) certification has been achieved. I prepared about 16 companies for FSSC 22000 and ISO 22000. QMS - I have prepared about 12 companies for 9001 certification has been achieved.

Sector: Medical Device Scope: Manufacture of (Catheters tubes, Cardiovascular Catheters, Fistula Needles, Blood lines and IV sets) Achievement: - Preparation and Successful certification for ISO 13485 and ISO 9001. - Preparation 7 technical file according to MDD 93/42/EEC. - Successful CE mark for 7 products. - Supervised validation: product, process, HVAC and sterilization. - 19 Successful MOH announced and unannounced audits. - Successful MOH license for 2 clean room and 1 control room.

Sector: Food Medical Device Sectors Scope: Manufacturing of carbon dioxide (CO2) and Medical Devices (Jars, Pressure gauges) Achievement: - Preparation and Successful certification for ISO/ FSSC 22000 & ISO 9001, ISO 13485 - Twice Successful COCA COLA certification “conditional Authorization” - Twice Successful PepsiCo certification “conditional Authorization” - Successful Schlumberger certification “conditional Authorization” - Part of food safety team, Traceability team.