I'm Junaid Ali, Pharmacy graduate (Pharm-D) with over four years of experience in pharmaceutical Quality Assurance in GMPregulated manufacturing. My work has covered in-process control, line clearance, CAPA management, deviation investigation, process and cleaning validation, Validation Master Plan execution, SOP development, documentation control, and audit readiness.
Currently based in Riyadh, Saudi Arabia with a transferable Iqama and immediate availability, willing to relocate.
Role and Responsibility;
* Prepared, reviewed, and implemented the Validation Master Plan (VMP) in line with GMP and regulatory requirements.
*Executed process validation and cleaning validation activities for manufacturing and packaging operations, ensuring consistent product quality and compliance with GMP standards.
* Coordinated qualification activities (IQ/OQ/PQ) for equipment, utilities, and manufacturing systems to support a continuously validated state.
*Lead qualification activities for critical systems including HVAC, water systems, compressed air, and cleanroom environments.
* Carried out thermal mapping studies for warehouses, cold rooms, and controlled areas to ensure temperature uniformity and compliance.
* Managed calibration activities, ensuring instrument accuracy, traceability, and adherence to defined calibration intervals.
* Supported Computer System Validation (CSV) activities in line with GAMP 5 and ALCOA+ principles to ensure data integrity and compliance of computerized systems.
* Prepared and reviewed validation protocols, reports, risk assessments, deviations, and change control documentation.
* Develop and execute Passivation and Sanitization protocols and reports.
* Provide support during internal audits, and regulatory inspections, presenting validation evidence and addressing findings.
* Develop, review, and maintain QA documentation, including SOPs, Batch Manufacturing Records (BMRs), Packaging Records, and other controlled documents to ensure accuracy and traceability.
* Dispense raw materials and perform in-process activities including line clearance, in-process checks.
* Inspect processes across manufacturing stages up to finished products and monitor adherence to GMP on a daily basis.
* Conduct and review Annual Product Quality Review (APQR) to monitor quality trend to ensure compliance.
* Collaborate with Production, QC, R&D, Engineering, and Regulatory Affairs to support validation and manufacturing activities and continuous process improvement.
* Monitor quality trends, investigate deviations, perform root cause analysis, and implement effective CAPA to optimize operations.
* Manage Deviation, Change Control, and related quality systems, ensuring timely closure and complete documentation.
* Provide training to QA staff on GMP, QA procedures, good documentation practices, and process improvement initiatives.
* Utilize SAP for batch release, process tracking and other QA related activities.
* Monitor Good Warehouse Practices including raw material, finished goods, and packaging material storage.
* knowledge of Regulatory Guidelines (FDA 21CFR, WHO, ISO, ICH, EMA, PICs amd other guidelines)
Skills;
Validation, Qualification, Documents control, inprocess control, SAP, Minitab, Thermal mapping, Water system validation, GMP Compliance, Deviation, CAPA, Change control.
Thanks and Regards
Junaid Ali
+966548568703
[email protected]