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Maria Amine, Quality Assurance Coordinator | Regulatory Affairs Specialist | Research & Development officer

Maria Amine

Quality Assurance Coordinator | Regulatory Affairs Specialist | Research & Development officer·Drugstore 3U

Lebanon

Master's degree, Pharmaceutical Industry

Work experience

Total years of experience: 5 years, 10 months

Quality Assurance Coordinator | Regulatory Affairs Specialist | Research & Development officer

March 2023 - Present

Drugstore 3U

Beirut, Lebanon

March 2023 - Present

• 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.

Company industry:
Pharmaceutical Manufacturing

QC Analyst

August 2022 - Present

BMA Paints Commercial and Industrial

Beirut, Lebanon

August 2022 - Present

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

Company industry:
Chemicals Manufacture
Job role:
Quality Control

R&D Analyst & Assistant LAB Manager

September 2022 - February 2023

BMA Paints Commercial and Industrial

Beirut, Lebanon

September 2022 - February 2023

• 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.

Company industry:
Chemicals Manufacture

QC Analyst Intern

April 2022 - July 2022

Mephico S.A.L

Beirut, Lebanon

April 2022 - July 2022

• 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.

Company industry:
Pharmaceutical Manufacturing

Assistant pharmacist

September 2020 - March 2022

Pharmacy Jezzine

Lebanon

September 2020 - March 2022

• 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.

Company industry:
Pharmacies
Job role:
Medical, Healthcare, and Nursing

QC lab and pharmaceutical production line Visit

May 2021 - May 2021

Benta Pharma Industries-BPI

Beirut, Lebanon

May 2021 - May 2021

• 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.

Company industry:
Pharmaceutical Manufacturing

Medical laboratory analyst

June 2019 - June 2019

Jezzine Governmental Hospital

Lebanon

June 2019 - June 2019

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

Company industry:
Medical Hospital
Job role:
Medical, Healthcare, and Nursing

Education

Lebanese university

January 2022

January 2022

Master's degree, Pharmaceutical Industry

Lebanon

Lebanese university

January 2020

January 2020

Bachelor's degree, Biochemistry

Lebanon

Skills

ANALYTICAL PROCEDURES
Intermediate
ANALYTICAL PROCEDURES
Intermediate
BIOCHEMISTRY
Intermediate
BIOCHEMISTRY
Intermediate
OPERATIONS
Intermediate
OPERATIONS
Intermediate
PHARMACEUTICALS
Intermediate
PHARMACEUTICALS
Intermediate
QUALITY ASSURANCE
Intermediate
QUALITY ASSURANCE
Intermediate
QUALITY MANAGEMENT SYSTEMS
Intermediate
QUALITY MANAGEMENT SYSTEMS
Intermediate
REGULATORY COMPLIANCE
Intermediate
REGULATORY COMPLIANCE
Intermediate
RESEARCH
Intermediate
RESEARCH
Intermediate
STANDARD OPERATING PROCEDURE
Intermediate
STANDARD OPERATING PROCEDURE
Intermediate
WAREHOUSING
Intermediate
WAREHOUSING
Intermediate

Languages

Arabic
Beginner
French
Beginner
English
Beginner

Training and Certifications

Certifications
FACA: First Aid, CPR & AED
GOOD CLINICAL PRACTICE