I'm Junaid Ali, Pharmacy graduate (Pharm-D) with over 5 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.
Role and Responsibilities:
* Managed and oversaw all IPQA activities ensuring full compliance with GMP, Regulatory requirements, approved SOPs, and batch manufacturing records at every stage of production.
* Performed routine IPC checks across all manufacturing stages dispensing, granulation, blending, compression, coating, filling, and packaging monitoring critical process parameters and quality attributes against validated limits.
* Carried out line clearance before and after each batch, verifying equipment readiness, area cleanliness, and proper material usage before approving production start-up at each stage.
* Conducted IPC sampling, physical testing, and documentation according to procedures using Disintegration Apparatus, Friability Tester, Hardness Tester, Moisture Analyser, pH Meter, and Conductivity Meter.
* Verified calibration and qualification status of IPC equipment, ensuring all instruments were properly maintained, valid, and functioning correctly before every use.
* Developed, maintained, and archived standardized BMR templates and completed Batch Manufacturing Records, ensuring documentation accuracy and compliance with GMP requirements.
* Reviewed batch records and operational records for completeness, accuracy, and GDP compliance, including correct error corrections, contemporaneous entries, and proper attribution.
Investigated deviations and non-conformances, reported findings promptly to QA management, and actively supported closure of CAPAs, change controls, and complaints through the QMS.
Contributed to process validation execution, cleaning validation sampling, thermal mapping, and IQ/OQ/PQ support for equipment and utilities across the facility.
* Drafted, reviewed, and updated SOPs for in-process control, line clearance, validation, and cleaning procedures in line with current GMP requirements.
* Prepared and reviewed APQRs covering batch yields, deviation trends, CAPA status, stability data, complaints, and change control summaries.
* Trained team members on GMP and QA procedures, monitored warehouse practices, and kept management regularly updated on team progress and quality performance.
* 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]