Experienced Quality Assurance with a demonstrated history of working in the pharmaceutical industry. Skilled in Pharmaceutics, product release, Annual product review, IPC for manufacturing and packaging Internal Audit, Good Distribution Practice (GDP), Good storage practice GSP), GMP Audit, , (Qualification and Validation. ) Data integrity, process validation, cleaning validation, computer system validation, water system validation, Commission and Qualification, Dry heat sterilization and compressed air qualification, Qualification of autoclave and pure steam, HVAC qualification and thermal mapping, Quality risk management, CAPA, Deviation, study quality tools (1- control chart,2cause and effect diagram,3-pareto chart,4-scatter diagram,5-flow chart,6Hisogram7-check sheet)through Minitab program, prepare training program for subordinate
· Review and preparation of batch documents for final release.
· Update Annual product Review record related to the batch information of the entire product manufactured.
· To represent QA inspection in all validation and qualification studies of process and systems.
· To ensure proper application of company policies and Current Good Manufacturing Practice in production, non-production area, manufacturing and packaging operation of each product for hourly release of product.
· To ensure the periodic review of all the reference sample is accomplished as per the schedule.
· To train properly newly hired inspectors to meet them in meeting QS objectives.
· To provide technical assistance and training to sub ordinate to maximize their performance without additional cost and to update them with cGMP.
· Document and report to QA management any failures, GMP violations, unsafe conditions or unusual results or practices.
· To prepare periodic reports for its evaluation to make sure that all activities are in line with QS objectives and I was assigned delegated as QA inspection supervisor with additional responsibilities with quality Assurance manager for any unusual incident in production or ware house area.
· Discus all problem encountered with all concerned department and involved in all corrective actions taken.
· Reviews process validation, equipment qualifications and company SOPs
· Conducts and supports corrective and preventive action program.
· Investigates customer complaints regarding quality.
Responsible for handling , disposing of product complaints and
· Collection of all bulk samples and semi-finished product samples as per material sampling instruction for each product and all reference ,stability .samples during packaging operation
· To record all manufacturing and packaging order no in the QA LOGBOOK
Performance improvement
undefinedOccupational health & Safety internal auditing
TUV SAUDIA ARABIA
· Associated with SPIMACO (Saudi Pharmaceutical & Medical Appliances Co)
• Internal Quality Auditing (ISO9001:2008
TUV SAUDIA ARABIA
Associated with SPIMACO (Saudi Pharmaceutical & Medical Appliances Co)
GMP TRAINING COURSE
SPIMACO AL -QASSIUM PLANT
· Associated with SPIMACO (Saudi Pharmaceutical & Medical Appliances Co)
• General Aseptic area course
SPIMACO AL -QASSIUM PLANT-KSA
· Associated with SPIMACO (Saudi Pharmaceutical & Medical Appliances Co)
• Safety BASIC AWARENESS TRAINING
SPIMACO AL -QASSIUM PLANT-KSA
Associated with SPIMACO (Saudi Pharmaceutical & Medical Appliances Co)
• GDP qualification for time and temperature sensitive product
webinar by quality department
· Associated with SPIMACO (Saudi Pharmaceutical & Medical Appliances Co)
• Applying Quality Risk Management
· · Associated with SPIMACO (Saudi Pharmaceutical & Medical Appliances Co)
A N O T H E R S K I L L S
L A N G U A G E S
CO U R S E S
· Dealing with Out of specification (OOS) Results through webinar by
· Associated with SPIMACO (Saudi Pharmaceutical & Medical Appliances Co)
Products stability and its relation to storage condition
SPIMACO AL-QASSIUM PLANT.-KSA
· Associated with SPIMACO (Saudi Pharmaceutical & Medical Appliances Co)
Out-of-Specification (OOS) and Deviation
· Associated with SPIMACO (Saudi Pharmaceutical & Medical Appliances Co)
Data Integrity and Documentation practice
· Associated with SPIMACO (Saudi Pharmaceutical & Medical Appliances Co)
· People Behavior and Cross Contamination through webinar by quality department on 24 January
· Associated with SPIMACO (Saudi Pharmaceutical & Medical Appliances Co)
• Industrial waste water treatment
Water Technology Expert Academy
Nanotechnology for environmental applications
Water Technology Experts Academy
·
Formulation development for Generic pharmaceutical products
Know -How Academy
HPLC Basic info webinar
Pharma peaks on line course
Sterile Manufacturing System Course
Valor Egypt for training and consultaion