taher glal ahmed

quality asuranceFull Time

• Job Details:1- conduct & Review process validation protocols and generate process validation reports (PVR) with statistical analysis charts of products (Vail & ampoule lines) 2- conduct & review media fill batch record which conduct every 6 month for (vial and ampoule ) lines then generate report for media fill (vial & ampoule)lines and review also evaluation & environmental data coming from microbiology department. 3- conduct evaluation cleaning validation for new products with worst case matrix for product A selection & product B selection in cleaning validation protocol. 4- conduct & review thermal mapping qualification reports of terminal Autoclave & (vial, ampoule autoclaves) for machine parts and garments then generate reports for coldest and hottest points in the autoclaves . 5- conduct IQ , OQ & performance qualification for Blistering Machine (tablet & capsule) products. 6- conduct & review performance qualification reports of thermal mapping storage area and cold rooms. 7- conduct & review performance qualification reports steam in place (SIP) of preparation and filtration tanks. 8- conduct & review (HVAC , LAFS & pass boxes) performance qualification reports in production and Microbiology department. 9- conduct & review tunnel qualification reports of (Ampoule, vial ). 10- conduct & review Annual Validation Plan for (process validation of products, HVAC system , LAFS, Pass boxes , SIP of tanks , Autoclaves , Media fill , Warehouse , cold rooms, Steam Quality Tests ,Compressed Air Tests ,Compressed Nitrogen Tests , cleaning validation) 11- review conducting calibration plan for (pressure gauges , temp sensors, digital balances, thermal ovens , etc.) 12- participate in deviation & change control related to Equipment qualification or process validation .