Quality Assurance Leader
Procter & Gamble
Total des années d'expérience :24 years, 9 Mois
I am leading quality team in my focus area to achieve the required business targets through building a high performing organization in my focus areas through being a discipline roll modeling. I always make the principle based decision-making strategy to be a life style to my team and myself. I am coaching people, follow up and results review during scheduled one on one meetings and through envisioning, engaging, empowering and enabling them to achieve the targets within a good team spirit. In addition to reward & recognition system to encourage people to love to work for P&G within P&G systems. In addition to building and improving the team capability, inspiring them by role modelling enthusiasm and dedication, helped achieve the business targets. I’m leading quality program health assessment (QPHA) across the whole plant. In addition to leading the implementations of the applicable reapplications from other P&G sites through leading reapplication matrix program (RAM).
Ensure that we manufacture, supply and use of correct starting and packaging materials
Ensure that the controls are properly set, including intermediates, bulk, calibration and validation
Ensure that the authorized persons releases the products, and ensure proper making, packing, storage, distribution and handling of the products
Ensure that there are approved standard operating procedures that describe in details and systematically (in the local language) how the operator will perform each single task across supply chain
Ensure that there is approved and active procedures for self-inspection and/or quality audits and for reporting, investigation and recording of deviations
Ensure that there is active and validated system for change management
Ensure that there are competent personnel, sufficient and clean design premises, equipment and facilities
Ensure that there is active and effective system for documentation and record keeping
Authorize standard master documents according to Procter & Gamble quality assurance program
Audit suppliers and improve their capability to supply high quality staring materials and components
Conduct internal quality assurance audits and tours on production lines periodically and ensure the operators on the production lines are familiar with quality goals and the quality culture is there
Conduct GMP training across the site to improve GMP/QA awareness for the people
Authorize consumer complaint final reports
Authorize quality assurance action plan (CAPA) and update Trackwise quality actions tracking system
Ensure that the current systems comply with the most update and recent requirements for quality assurance, cGMP and clean design standard
Present and participate quality assurance results with the upper management
Ensure that the products are designed and developed correctly complying with regulations, good manufacturing practice (GMP) and P&G quality assurance program requirements
Clean design standard implementation for equipment, process, procedures and formulations
Microbial risk assessment (MRA) and change management for equipment design, formulation, procedures and master defect list (MDL) tracking and update to eliminate any type of microbial risk
Authorize water treatment unit design and water system validation
Leading the validation of utilities/facilities (Nitrogen generator, ozone generator, compressed air, HVAC...) in terms of IQ, OQ and PQ
Leading and authorizing making and packing liquid operations cleaning and sanitization validation process by different techniques (Steam, hot water, chemicals (hypo chloride, Alcohol)…)
Developing microbial control strategy across the site and define the risk areas and micro quality factors to minimize the risk during manufacturing and to set microbial sampling plan to control and monitor all risk points (factors)
Leading the investigation process for microbial contamination (nonconformance) cases
Improving microbiological awareness and organization capability through frequent sessions of microbial quality management courses
Microbial daily management (MDM) program author
Present and share microbiology systems integrity & results with site leadership team and regional microbiologists
Develop microbiology culture and clean design knowledge across other sites within the region and conduct microbial risk assessment for the whole supply chain including making and packing operation and in microbiology laboratories
Since July 2006 to Present
Leading microbiology lab in Cairo plant (3 microbiologists were reported to me)
Microbiology laboratory design revision & authorization
Managing all standard documents for microbiology lab (SOPs, Technical Standard, Equipment validation protocols)
Managing microbiology lab chemicals & reagent (Expiration, inventory & Records)
Site bio-safety owner
Leading the setup of QC department annual/quarter priorities, game plan & master plan according to site annual compiling business need
Managing QC individual work plan and evaluation and performance tracking (11 analysts)
Managing quality control of granules & liquids in Cairo plant
Monitoring quality measures for granules & liquids (Cr, Tz, PPM, SQM PPM, and CuC)
Managing lab safety program and leading Fabric & Home Care dust sample analysis by ELISA technique
QC department reword & recognition system owner
Career path planning and promotion recommendations for team member that I lead
Setup training system for quality department and setting the training plans
Training system results tracking and gab analysis and action plan following up to improve people capabilities
Leading quality department Work Process Improvement (WPI) systems to eliminate losses
Fabric &Home Care / Beauty Care finished product, Raw & Packing material analysis through validated test methods & release (SAP R3) according to quality assurance requirements
Equipment calibration and solutions & reagents preparation, standardization and expiration tracking
Leading technical standard system in main lab and managing physical standard program
Leading panelists selection & ongoing qualification for panelists (beating average - & internal COOP program)
Managing Middle East & Africa region for fabric & home care finished product COOP program
Have a strong operating & trouble shouting handling for several measuring instruments like HPLC, Spectrophotometer, Horiba, GC
Gypsona & dialyzer filter production planning according to site master production plan
Medical devices sterilization process leader (ethylene oxide technique)
Gypsona production operations (making - packing lines) leader
Dialyzer filter production process leader
Process control strategy development in Gypsona, dialyzer filters & sterilization operations
Develop standard operating procedures for making & packing operations
Managing & leading validation process for (equipment, systems & procedures)
Inventory tracking, loss analysis and action plan development and follow up
Productivity tracking & improvement and labor evaluation and recognition
Studied major and nuclear chemistry