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Job Description
- Revision of manufacturing batch documentation and preparation of documentation for final product release to the market.
- Performance of visual inspections and temperature record reviews of final product.
- Performance of product recalls simulations.
- Completion and on time closure of deviation investigations, ensuring that robust investigations
are performed and appropriate CAPA’s implemented. - Involvement in site quality systems, deviations, change controls, SOPs and self-inspections.
- Actively maintain and promote a cGMP compliant culture, ensuring the compliance with
Egyptian Regulation, in accordance to EU and USA requirements and with approved licenses. - Support regulatory inspections received by Health Authorities.
Job Requirements
- Bachelor’s Degree in Health-related Sciences preferably pharmaceutical area.
- Comprehensive knowledge and understanding of cGMPs, FDA regulations, and industry guidelines.
- Minimum of 2 years of related quality / product release experience in a pharmaceutical, GMP or FDA regulated environment is required.
- Requires in-depth understanding of pharmaceutical manufacturing, and quality review relating
to production batch records. - Computer literacy with proficiency in MS Office (Outlook, Word, Excel, PowerPoint).
- Specific experience with SAP is preferred.
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