Deputy Manager
MS PHARMA INJECTABLES
مجموع سنوات الخبرة :20 years, 2 أشهر
Manage and coordinate the following activities:
Environmental monitoring program in aseptic filling & terminal sterilization production areas.
Follow up for disinfection regime in aseptic, terminal sterilization production areas and microbiology lab.
Personal qualification & disqualification in sterile production area and retraining if needed.
Training sessions: behavior in clean rooms, Gowning in Aseptic filling production areas, disinfection and sterilization in aseptic filling production areas.
Preparing and reviewing validation protocols:
Media fill protocol.
Media Selection protocol.
Closure integrity testing protocol.
Autoclaves, tunnel validation protocol.
Cleaned and to be cleaned equipment holding time.
Culture media stability protocol.
Preparing, reviewing and approving SOPs in quality control department.
Risk assessment in quality control department.
Implementation for OOS procedure in quality control department.
Sterility testing by closed system.
Bioburden test for raw materials and in process samples.
Endotoxin test by LAL: PH profile compatibility
Inhibition/Enhancement Test, quantitative test.
Chemical and microbial monitoring of water treatment unit.
Biological assay.
Fo, FH, Fd calculations.
Pest control program.
Familiar to GMP, FDA, PDA, PICs requirements.
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