Senior Quality Assurance Quality systems Job Tabuk area,Tabuk Region Saudi Arabia,Quality Assurance

Responsibilities

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.
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.
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.
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.
Audit Coordination:
Facilitate external and regulatory audits, managing requirements, identifying necessary systemic improvements (CAPA), and ensuring timely closure of audit findings.
Documentation Control:
Manage the issuance and lifecycle of Logbooks, SOP controlled copies, and technical documents, ensuring strict adherence to documentation protocols across all departments.
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).
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.
Leadership Support:
Act as the designated backup for the QA Supervisor, ensuring continuity of quality operations and decision-making processes.
Operational Agility:
Contribute to cross-functional QA activities as assigned, including IPC oversight during peak periods or personnel transitions to maintain seamless quality coverage.

Qualifications

Required Educational Level and Certificates:
Bachelor Degree in Pharmacy, Science, Medicine or Chemistry.
Required Experience: 5-7 years of experience in a similar position.