Fady Malaty Email & Phone Number

Laverton North, VIC, AU

Melbourne, Victoria, Australia

• Responsible for leading a team of 25 Laboratory Technicians and acting as a Manager in their absence
• Issuing clear and complete standard operating procedures (SOPs) and work instructions, facilitating miscellaneous training sessions to Quality Control (QC) team members, and focusing on data integrity
• Ensuring daily compliance with Current Goods Manufacturing Process (CGMP) regulations and following Therapeutic Goods Administration (TGA) regulatory guidelines

Melbourne, Australia

• Overseeing the daily operations of analysing raw materials, bulks, finished products and stability samples, as well as authorising the release of raw materials, bulks, and finished products
• Collecting and compiling statistical quality data and controlling document management systems
• Analysing product defects, batch failures, process deviations, or out-of-specification (OOS) investigations, deviations, complaints, and conducting laboratory investigations to determine the root cause by using quality.

Sydney, Australia

• Analysed multi-vitamins in the following forms: finished products, raw materials and in-process products
• Analysed new company products submitted by the R&D department
• Performed routine evaluation of raw materials, intermediate and finished pharmaceutical formulations along with packaging components as per SOPs

Egypt

• Updated specifications of finished products or intermediate bulk according to the manufacturer’s and master batch record needs
• Prepared SOPs, work instructions, intermediate and finished products specifications and test methods according to European, USP NF and British Pharmacopoeias and / or licencor specifications
• Supervised Specialists, Analysts and Assistant Analysts on a daily basis

Minapharm Co. Pharmaceutical Chemical Industries

• Lead internal audits within different company departments using audit criteria of ISO 9001, 14000 & 18001
• Set Key Performance Indicators (KPIs) for the QC department and monitored the measured results and set quality tactics and SMART objectives for QC department to align with strategic goals
• Conducted the new finished products projects and stability samples for the following international companies: Johnson & Johnson, Janssen PHARMACEUTICA Belgium, Novartis, SCHWARZ Pharma Germany, GSK, Merck Santé France.

Diploma, Certified Manager Of Quality & Organizational Excellence

Diploma In Total Quality Management (Tqm)

Field of study: The Basic Six Sigma Breakthrough Improvement process, Statistical Quality Control, Standards for Quality and Environmental.

Bachelor'S Degree, Pharmaceutical Sciences

Field of study: Analytical Chemistry, Pharmacology, Pharmaceutics, Pharmaceutical Chemistry, Phyto Chemistry, General & Applied.