John Medhat

Supervising IPC and Qualification activities within sterile facility

Responsibilities and Achievements
1) Responsible for Validation/Qualification, Compliance and IPC activities within sterile production facility
(Ampoule/ Vial/ Blow Fill Seal technology).
2) Responsible for EU Audit gap analysis preparation, tasks communication and follow up with company departments.
3) Passed EU Audit on sterile facility without critical or major observation.
4) Passed Gabon Audit on sterile facility without critical or major observation.
5) Passed periodic MOH audit on sterile production facility, without critical or major observation.
6) Responsible for Risk assessment preparation for the campaign production project within sterile production facility.
7) Responsible for Risk assessment preparation for Remdesivir Antiviral hazard drug product production within a shared
facility.

Responsibilities and Achievements
1) Material Management and Supplier Qualification.
2) Risk Management Support.
3) Deviation Support.

Horus 10th
of Ramadan Facility
Responsibilities and Achievements
1) Sterile project startup quality member.
2) Quality assurance documentation handling:
• SOPs/WIs creation.
• Validation/Qualification protocols and reports creation.
3) Execution of machinery/system IQ/OQ/PQ.
4) Calibration plan preparation and activities follow up.
5) Sterile production IPC, environmental and water monitoring.
6) Deviation, Change control and Risk assessment handling.
7) Production batch record review.
8) Internal and external audit handling.
9) Ministry Of Health (MOH) visit handling.
10) Training of subordinates:
• On the job training (OJT).
• Planned training sessions.
11) Validation plan preparation and handling of:
• Cleanroom validation.
• Aseptic process validation (Media fill test).
• Process validation
• Moist heat thermal validation.
• Dry heat thermal validation.
• CIP cycle/cleaning validation.
• Vial/Amp. washer machine validation.
• Vial/Amp. filling machine line qualification
• BFS filling machine line qualification
• Deep cleaning/fumigation validation
• Gowning qualification
• Visual inspection qualification

Responsibilities and Achievements
Responsible for the sales & promotion of Pantogar®
, Texacort®
, Pramover®
, Enrich plus®
,
Diosmin®
, Savibleed®
, Marcal®
& Resinokaten®
in Embaba and Embaba centers