HomeAccounting / FinanceQuality Regulatory Compliance Specialist
Quality Regulatory Compliance Specialist
Amoun Pharmaceutical
Obour City, Cairo, Egypt
Accounting / Finance Confidential 16 hours ago
Experience الخبرة
1 To 3 Years
Career Level المستوى
Entry Level (Junior Level / Fresh Grad)
Education التعليم
Bachelor's Degree
Salary الراتب
Confidential
Skills Required المهارات المطلوبة
Quality Pharmaceutical Regulatory Compliance (EDA NFSA NRC) Documentation & Data Management Attention to Detail & Data Accuracy Regulatory Documentation & Submission Raw Materials Release & Sampling CADC Submission & Follow-up COA (Certificates of Analysis) Preparation SAP (especially data handling / SAP QM) Compliance Finance Pharmaceutical Pharmacy QC Quality Assurance Quality Control Regulatory Affairs
Job Description الوصف الوظيفي
The job holder will manage and execute regulatory compliance activities for raw materials and finished products, including data preparation, documentation, submissions, and follow-up with regulatory authorities (EDA, NFSA, CADC, NORCB). Acts as primary owner for Raw Materials, COAs, and CRM activities while supporting finished product operations based on workload distribution. Position will be based in our site in Al Obour City and will report to Site Quality Assurance Manager. Your Responsibilities:   Full ownership of EDA release, sampling, NFSA (imported & local) for raw material tasks including data preparation, document verification, submission, and SAP release. Raw Materials CADC Management: Prepare and upload CADC files, follow up on analysis results, and manage retained and expired samples. COAs Creation: Create Certificates of Analysis for raw materials and finished products including first batches, random samples, new suppliers, biological and stability products. CRM Management: Handle all CRM activities including accreditation, extensions, whitelist, and coordination with QC and CADC Finished Products Support: Support sampling, CADC submissions, and regulatory documentation for finished products Archiving: Maintain proper archiving of all reports and compliance documents. Financial Tracking: Monitor EDA & NFSA & NRC & EDA Ref Lab fees and support budget calculations
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