Microsoft Office (Word, Powerpoint, Excel)
Martina Ibrahim
Quality Assurance Specialist
El Sheikh Zayed
Summary
Determined, hard worker and dependable candidate with over three years of experience in the quality assurance department and sterile production area. My expertise also extends to handling of deviation, change control, and complaints, conducting internal audits, and doing risk assessments.
Detail-oriented team player with strong organizational skills eager to help the team achieve company's vision.
Overview
3
3
years of professional experience
5
5
years of post-secondary education
10
10
Certifications
Work History
Validation Specialist
SigmaTec Pharmaceutical Industries
01.2024 - Current
- Performing validation activities as described in validation protocols including thermal studies, process, and cleaning validation.
- Responsible for Clean Room Qualification Activities for classified Areas and LAF Units.
- Executing Qualification studies for equipment (Production Machines, Autoclaves, Tunnels, Ovens, Incubators, Refrigerators, Cold Stores… etc.) and HVAC systems according to the approved qualification plan and protocols.
- Issuing Calibration Certificates for internally calibrated items, along with assisting third party calibration company and keeping external calibration certificates.
- Preparing VMP for the facility as per the latest guidelines, and all documents needed for different validation activities.
Quality Assurance Specialist (Compliance)
Eva Pharma for Pharmaceutical industries 2
3 2023 - 12.2023
- Recording and investigating any incidents, deviations, or changes in the manufacturing process, implementing appropriate corrective and preventive actions (CAPA) to ensure their non-recurrence in the future.
- Assisting in conducting internal audits, focusing on the warehouse, engineering , quality control and Microbiology Laboratories.
- Participating as audit facilitator to external auditors throughout the external audits.
- Assisting multiple departments, including engineering and production, in ensuring compliance with regulations and industry standards.
- Handling of Complaints and Recall.
Production Specilaist
Sigma Pharmaceutical Industries
05.2021 - 02.2022
- Requesting batch records from documentation department.
- Calculating raw material actual weight through using percentage assay and loss on dry found in the raw material certificates.
- Receiving the raw material from weighing area and double checking the weights before preparation.
- Preparing the sterile product in an aseptic manner followed by supervising the double filtration procedure, and following up the filling process of the sterile product through checking the visual inspection of ampoules.
- Supervising the packaging procedure starting from receiving secondary packaging materials from warehouse til delivering finished product to the warehouse.
- Reconciliation of Batch Record
- Responsible for training subordinates, operators, and workers on Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs).
- Monitoring the workers' adherence to Good Manufacturing Practices (GMP) outlined in the operating papers throughout the production process.
- Overseeing the recording of processing, preparation, and filling steps in the batch record.
- Prioritizing the accurate recording of the data in the logbook, which was reviewed periodically.
Education
Bachelor of Pharmaceutical Science -
Modern University of Sciences And Arts
Egypt 05.2015 - 05.2020
Skills
Analytical
Software
Languages
Arabic
Native language
English
Advanced
C1
Certification
Training and Development Unit Certificate From Baheya Foundation
Timeline
Validation Specialist
SigmaTec Pharmaceutical Industries
01.2024 - Current
ELearning Foundations of GMP: Active Pharmaceutical Ingredient (API)
09-2023
ELearning: Foundations of GMP: Deviations, Root Cause Analysis (RCA) Tools and Corrective and Preventive Action (CAPA) - Sequence flow for handling of any non-conformance in the GMP environment
09-2023
ELearning Foundations of GMP: Medicinal Products
09-2023
ELearning: Foundations of GMP: Qualification
09-2023
ELearning Foundations of GMP: Quality Risk Management
09-2023
ELearning: Foundations of GMP: Water Systems
09-2023
ELearning: Foundations of GMP: Validation
09-2023
ELearning: Foundations of GMP: Auditing
09-2023
Production Specilaist
Sigma Pharmaceutical Industries
05.2021 - 02.2022
Critical Care Pharmacy Certificate Program from 57357
03-2021
Training and Development Unit Certificate From Baheya Foundation
09-2019
Bachelor of Pharmaceutical Science -
Modern University of Sciences And Arts
05.2015 - 05.2020
Quality Assurance Specialist (Compliance)
Eva Pharma for Pharmaceutical industries 2
3 2023 - 12.2023
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