Qualified Person (PV QA Manager)

Job Description

● Support all Regulatory Affairs activities in order to achieve and maintain registrations in compliance with all national and regional Regulatory and legal obligations for import and local manufacturing. ● Effectively manages priorities in order to implement corrective and preventive actions. ● Appropriately applies principles of continuous improvement. ● Annual product reviews and review of stability reports for compliance with Food and Drug Regulations. ● Monitoring QA aspects of warehousing practices for compliance with warehouse procedure manuals. ● Timely approval of incoming batches, batch inspection and release according to SOPs. ● Liaising with customers and regulatory authorities regarding quality matters, including inspections and responding to observations. ● Write, review and approve GMP documentation for MOH such as SMF, Quality Manual, CTD, Material/Personnel/Waste/Sample flow drawings, etc. ● Write, review and approve GMP documentation (SOPs, protocols, technical reports, technology transfer protocols, specifications, summary reports to support GMP production, change controls, etc.). ● Review batch records, associated testing records, and other documentation to ensure that all steps have been executed correctly, verified where applicable, and that all limits and specifications have been met. ● Develop and maintain Quality Agreements with contract manufacturers, suppliers, and laboratories. • Review and approve Validation Protocols and reports to ensure compliance. ● Support Annual Product Review report generation and approval. ● Review protocols, analytical results, and documents associated with investigations, OOS results, ● Conduct internal audits, track progress, and trend results. ● Participate in relevant supplier audits as needed. ● Review relevant sections of regulatory filings. ● Compliance of batch manufacturing as per market authorization requirements.