ماريا أمين

• Oversee GSDP (Good Storage and Distribution Practice) compliance across all
warehouse and transport operations.
• Develop, implement, and update Standard Operating Procedures (SOPs) to
ensure regulatory and quality standards are met.
• Implement the Quality Management System (QMS) in alignment with GSDP
requirements and company objectives.
• Manage regulatory submissions and maintain product registration dossiers in
compliance with national authority requirements.
• Conduct internal audits, risk assessments, and CAPA follow-up to ensure
continuous quality improvement.
• Successfully prepared and passed external GSDP audit, ensuring full
compliance with regulatory standards.
• Liaise with suppliers, manufacturers, and health authorities to support
regulatory and quality activities.

• Routine calibration of laboratory instruments (balances, viscometer, oven…)
• Testing of raw materials.
• Provide countertypes for raw materials.
• Conduct the stability test of finished products.

• Eventually working directly with customers to ensure complete satisfaction
with finished products.
• Strong commitment to Operational Excellence in lab, office and industry.
• Perform equipment maintenance and troubleshooting.
• Experience in the conduct of developmental research trials to develop a new
product.
• Effectively communicate in team meetings, activity coordination and program
updates.
• Understanding of manufacturing process.
• Good relationship with suppliers.
• Problem solving & decision making skills.
• On site visits to customers to resolve problems related to the products.

• Conducted laboratory testing in FDA regulated environment in accordance
with GMP.
• Performed troubleshooting, repairs and calibration of laboratory equipment.
• Performed analysis using USP/NF monographs.
• Conducted drug purity assays using HPLC, UV/vis spectrophotometer.
• Documented all laboratory testing and activities in accordance with GMP
documentation practices.
• Quality control inspection on the manufacturing process.
• Worked on a thesis of validation of analytical method used in quantification of
residuals of drug product after cleaning of production equipment.
• In-process tests on semi-finished products.

• Advising patients on the appropriate usage and dosage of medication
inclusive of any precautions and potential side effects.
• Collaborated with physicians to best support patients.
• Filled and verified prescriptions.
• Improved sales of over the counter drug by reorganizing shelves and
introducing seasonal displays.
• Disposal of expired medications according to regulations.
• Provided instructions and information to patients on safe and effective use of
medicines.

• Testing of finished products in accordance with GMP guidelines.
• Visit to the Microbiological Lab and conduct microbiological tests.
• Visit to the production line and know-how of the manufacturing process.

• Conducted lab tests in the areas of hematology, coagulation, urinalysis,
serology, cell count and immunology.
• Blood collection techniques.
• Blood type test.