Syed Anwar Kamal

Manage quality activities for pharmaceutical and vaccine products across manufacturing and commercial supply, including deviations, change controls, product complaints, CAPA, and risk management. Chair local incident committees, participate in PIRCs and recalls, and act as recall coordinator using GSK quality systems. Coordinate internal and external audits for distributors, 3PL warehouses, and transporters, manage third-party quality agreements and DRAs, and approve batch release decisions. Produce KPI reporting and analytics using Power BI and quality dashboards within Veeva.

Oversaw quality-related work for manufactured and supplied pharmaceutical and vaccine products, including review and approval of distribution risk assessment, technical terms of supply, and quality agreements. Led management monitoring audits (MM and IBM) and managed ongoing commercial compliance reviews and quality audit processes. Conducted and led audits of distributors, driving CAPA planning and closure, and supported quality councils and risk board updates. Developed quality procedures and audit processes to strengthen the site quality management execution.

Supervised quality compliance staff responsible for document management (DMS), batch dossier review, and archiving of batch records and retained samples. Ensured the site complied with GSK QMS requirements and applicable regulatory guidelines, including controls for SOPs, batch manufacturing/packing instructions, and record retention. Conducted internal audits (including IBM L2 and management monitoring L1) and led vendor audits focused on quality and technical risk. Managed deviations, change controls, CAPAs, product complaints, periodic product reviews, and supported inspection readiness with escalations when needed.

Inspected production areas covering manufacturing, dispensing of raw materials, and packaging to ensure adherence to manufacturing instructions and production SOPs. Performed routine sampling of raw materials and intermediate products and issued in-process check reports for quality review discussions. Participated in developing local quality SOPs in line with GSK standards and supported checking of critical instruments used in production. Helped investigate and highlight anomalies during quality review and council meetings.