MOHAMMED ALARABI
Riyadh
Summary
Supervisor quality assurance with 8 years solid experience in pharmaceutical industry and all activity of quality to improvement the system as well as Builds productive working relationships to increase engagement with improvement strategies.
Overview
9
9
years of professional experience
Work History
Quality Assurance Supervisor
Riyadh Pharma
12.2020 - Current
- Lead and oversee aseptic manufacturing activities within Grade A/B cleanrooms, ensuring full compliance with GMP Annex 1 and ISO 14644 requirements.
- Supervise gowning and aseptic technique practices, control personnel flow, and verify gown integrity and pre-entry procedures prior to entering sterile zones.
- Plan, execute and review media-fill (aseptic process simulation) studies and execute immediate investigations and corrective actions in case of deviations.
- Manage environmental monitoring program (viable and non-viable monitoring, surface and personnel sampling), interpret trends, and trigger containment and CAPA when criteria exceed limits.
- Implement and verify line clearance and time clearance procedures before batch start to eliminate mix-ups and cross-contamination (remove previous product, labels, tools)
- Responsible for following up and reviewing all process documented in Batch Manufacturing Records (BMR/BPR), guaranteeing accuracy, GMP compliance, and timely release through the ERP system.
- Follow up and supervise autoclave operations, including cycle parameters and performance tests, ensuring compliance with GMP requirements. Monitor purified water systems
- line clearance activities inside sterile areas, and strict adherence to gowning procedures.”
- Monitor BMS (Building Management System) and particulate levels during sterile manufacturing processes and cleanroom activities. Ensure continuous compliance with defined environmental limits, investigate any excursions, and implement corrective actions to maintain aseptic conditions.
- Preparing ,reviewing and maintaining SOPs of the IPC department, and IPC sampling plan.
- Conducted visual inspections of cleanrooms, equipment, and production lines to verify readiness and compliance prior to batch release.
- Supervised line clearance and time clearance activities, eliminating risks of cross-contamination and product mix-ups.
- Ensured compliance of purified water systems and cleanroom utilities, maintaining quality within defined specifications.
- Led challenge tests and machine qualifications to verify equipment integrity and operational consistency.
- Managed environmental monitoring programs (viable / non-viable particulates, surface, and personnel monitoring) and trended results for continuous improvement.
- Maintained cleanroom requirements, including HVAC control (temperature, humidity, differential pressure), and executed periodic IQ/OQ/PQ validations.
- Verified cleanroom classification across Grades A–D, ensuring adherence to international regulatory standards.
- Investigated deviations during sterile operations, initiated CAPA, and ensured timely closure with documented effectiveness.
- Participated in internal and external audits to ensure compliance with cGMP and international standards.
- Provided training and guidance to staff on quality standards and aseptic practices.
- Followed risk assessment protocols to prevent contamination and ensure product safety.
Senior Quality Assurance Validation and IPC
Macro pharmaceutical
09.2020 - 12.2020
Quality assurance specialist
Penta pharma
02.2018 - 08.2020
Quality inspector
AL-Esraa Pharmaceutical Industry
06.2016 - 01.2018
Education
Faculty of science - Chemistry& Microbiology
Sohag University
Skills
- GMP
- Conformity inspections
- Root cause problem-solving
- Batch record verification
- Non-conformance reporting
- Leadership
- 5-why analysis
- Process validation
- Risk assessment
- Process control
- Compliance monitoring
- Process improvement
- Microsoft office
- Process improvements
Affiliations
- Reading ,Football, swimming
Languages
English
Advanced
Arabic
Fluent
Personal Information
Timeline
Quality Assurance Supervisor
Riyadh Pharma
12.2020 - Current
Senior Quality Assurance Validation and IPC
Macro pharmaceutical
09.2020 - 12.2020
Quality assurance specialist
Penta pharma
02.2018 - 08.2020
Quality inspector
AL-Esraa Pharmaceutical Industry
06.2016 - 01.2018
Faculty of science - Chemistry& Microbiology
Sohag University
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