Senior Quality Assurance ( Quality systems )

1.

SAP & Master Data Governance: Managing and overseeing Quality-related modules in the SAP system, (e.g., material masters, inspection plans, and quality info records) to ensure accuracy of master data & data integrity and compliance.

2.

Investigation & CAPA Management: Lead the review of non-conformances and market complaints, ensuring all investigations are exhaustive, root causes are identified, and Corrective and Preventive Actions (CAPA) are implemented and verified for effectiveness.

3.

OOS & Manufacturing Investigations: Oversee the review of Out-of-Specification (OOS) results, ensuring rigorous manufacturing investigations and technical evaluations are conducted in compliance with regulatory standards.

4.

Quality Risk Management (QRM): Evaluate and approve quality risk management records, ensuring that mitigation strategies are robust, CAPAs are aligned, and residual risks are maintained within acceptable limits.

5.

Audit Coordination: Facilitate external and regulatory audits, managing requirements, identifying necessary systemic improvements (CAPA), and ensuring timely closure of audit findings.

6.

Documentation Control: Manage the issuance and lifecycle of Logbooks, SOP controlled copies, and technical documents, ensuring strict adherence to documentation protocols across all departments.

7.

DMS & Technical Support: Provide high-level support for QA documentation activities, including the review and synchronization of DCRs, SOPs, and Master Lists within the Document Management System (DMS).

8.

Product Quality Review (PQR): Preparing & uploading of product quality review reports (PQR) for Tabuk & Multinational products according to SOP, current GMP and corresponding quality agreements.

9.

Leadership Support: Act as the designated backup for the QA Supervisor, ensuring continuity of quality operations and decision-making processes. 10.

Operational Agility: Contribute to cross-functional QA activities as assigned, including IPC oversight during peak periods or personnel transitions to maintain seamless quality coverage.