Summary
Tabuk Pharmaceuticals is seeking a Senior Quality Assurance professional focused on quality systems in Tabuk, Saudi Arabia. The role oversees SAP quality master data, investigations, CAPA, OOS reviews, quality risk management, audits, and controlled documentation. It also supports DMS activities and prepares product quality review reports in line with SOPs, current GMP, and quality agreements. Applicants are required to hold a bachelor’s degree in Pharmacy, Science, Medicine, or Chemistry and have 5–7 years of experience in a similar position.
The posting
As published on tabukpharmaceuticals.com. Pulled from the employer's site and shown as they wrote it.
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.
Required Educational Level and Certificates : Bachelor Degree in Pharmacy, Science, Medicine or Chemistry.