الملخص
تعلن Tabuk Pharmaceuticals عن وظيفة أخصائي أول ضمان الجودة، مع التركيز على أنظمة الجودة في تبوك، المملكة العربية السعودية. تشمل المسؤوليات الإشراف على بيانات الجودة في SAP، والتحقيقات والإجراءات التصحيحية والوقائية، ومراجعة نتائج OOS، وإدارة مخاطر الجودة، والتنسيق للتدقيقات والوثائق الخاضعة للضبط. كما تشمل دعم أنشطة نظام إدارة الوثائق وإعداد تقارير مراجعة جودة المنتجات وفق إجراءات التشغيل المعتمدة وممارسات التصنيع الجيد الحالية واتفاقيات الجودة. يُشترط الحصول على درجة البكالوريوس في الصيدلة أو العلوم أو الطب أو الكيمياء، وخبرة من 5 إلى 7 سنوات في وظيفة مماثلة.
نص الإعلان
كما نُشر على tabukpharmaceuticals.com. نقلناه من موقع صاحب العمل ونعرضه بنصّه الأصلي.
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.