I hold a degree in Pharmacy and working as a QA Officer at Herbion Pakistan, with prior experience at Regal Pharma. Over the 4 years of experience, I have gained extensive experience in pharmaceutical manufacturing as a Quality Assurance, In Process control, Line Clearance, Validation, and GMP operations. Skilled in batch record review, deviation and CAPA management, equipment qualification (IQ/OQ/PQ), and audit support.
Currently residing in Saudi Arabia with transferable iqama and actively seeking opportunities in pharmaceutical manufacturing and quality operations.
Experience in;
• Prepare and execute Validation Master Plans (VMP), and conduct Process Validation, Cleaning Validation, Hold Time Study and Equipment/Facility Qualification as per regulatory and GMP requirements.
• Develop and execute Passivation and Sanitization protocols and reports.
• 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.
Conduct physical testing of products using equipment such as Moisture Analyzer, Disintegration Apparatus, and Friability Tester, Hardness tester, Torque tester.
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]