Innovative. Industrious. Talented, a highly competent, motivated and enthusiastic Quality Management System and Compliance with experience of working as part of a team in a busy office environment. Well organized and proactive in providing timely, efficient and accurate technical and administrative support to industry requirement and work colleagues.
1 . Quality Assurance Management :
- Quality Management System (QMS) Oversight: Designs, implements, and maintains robust QMS processes, including in-process controls
and quality gates, ensuring built-in quality, safety, and traceability from production to customer.
-Customer Satisfaction & Complaint Management: Manages customer complaints, ensuring thorough investigation, closure, and analysis of
Cost of Quality (COQ) losses, implementing corrective and preventive actions (CAPAs).
-GxP Compliance & Product Quality: Steers GxP activities, acts as Qualified Person (QP) for product release, and ensures compliant GxP
services and gases, maintaining product quality, safety, efficacy, and traceability.
-Product Development & Validation Lead: Establishes and structures validation activities for machinery, systems, products, and processes,
aiding in product development and evaluating quality KPIs for continual improvement.
-Supplier & Risk Management: Develops and maintains supplier qualification systems and implements comprehensive quality risk and
opportunity management based on ISO and ICH guidelines.
2. Quality Control Management :
-Establishes and documents technical operational requirements for analyzers, including quality control and inspection procedures for
subordinates.
-Serves as the focal point for analysis management, ensuring metrology compliance with relevant authorities and establishing criteria for
analysis and confidence levels.
-Leads analytical training, daily equipment verification, and method validation, developing criteria based on manufacturer references and
technical knowledge.
-Develops and implements quality inspection protocols to minimize losses, reduce customer complaints, and enhance the company's image.
-Oversees and evaluates Quality Control activities across different sites, ensuring standardization and high confidence in analytical results
through communication and checks.
3- Compliance , IMS and Cross functional Steering :
-Deviation Management & CAPA Lead: Oversee deviation detection, root cause investigation using various problem-solving tools (Fishbone,
5 Why, 8D, Cost-benefit analysis, Value Stream Mapping, Six Sigma), and ensure effective corrective and preventive actions across the
organization.
-Audit Management (Internal & External): Develop and implement annual internal audit/self-inspection programs against ISO standards
(9001, 14001, 45001, FSSC 22000, IMS GP's, GT's) and lead external audits from regulatory bodies, certification bodies, and customers to
ensure compliance and continuous improvement.
-Food Safety Team Leadership: Ensure full compliance with FSSC 22001, customer, and regulatory requirements, including hazard
identification, food fraud, and food defense measures
-Quality Regulatory Compliance & Affairs: Guarantee QMS adherence to relevant regulatory requirements through cross-functional
alignment and manage communications with regulatory bodies (MOH, NFSA, EOS, etc.) to assess risks and opportunities.
-QMS & IMS Management Reviews: Draft and oversee management reviews to enhance feedback loops and continuously improve the
Quality Management System and Industrial Management System.
-Quality Culture & Cross-functional Steering: Drive certification training and personnel qualification to elevate the organization's quality
culture, incorporate quality gates in various functions, and support Quality Assurance Agreements for contracted services.
-Act as Local Pharmacovigilance and Medical Query Officer, I establish and manage all PV activities for Air Liquide Egypt. This includes
training, case reporting, documentation, complaint reconciliation, third-party management, and responding to ALSI Vigilance Quarter
Questionnaires.
Team Building and management
ISO 9001 :2015 Lead auditor
FSSC 22000 V6 Lead auditor
ISO 9001 :2015 Lead auditor
Leadership Journey
Highfield Level 3 Award in Food Safety
Quality Management & Stakeholder Management
Time Management and Goal Planning
DATA ANALYSIS CHALLENGER
ISO 14001 & 45001 Auditor Training
LSSGB Lean Six Sigma - Green Belt