Overview
Quality Assurance Manager Jobs in Giza, Al Jizah, Egypt at Magnet
Title: Quality Assurance Manager
Company: Magnet
Location: Giza, Al Jizah, Egypt
Industry: Pharmaceutical Manufacturing.
Job Location: Giza
Responsibilities:
Lead and manage FDA audits, ensuring successful outcomes and full compliance with FDA regulations.
Oversee internal and external audits, ensuring strict compliance with regulatory guidelines.
Manage validation and in-process control activities to guarantee product quality and consistency.
Monitor and ensure compliance of utilities, water systems, and environmental conditions to maintain quality standards.
Review and approve annual Product Quality Review (PQR) reports and stability programs.
Evaluate and resolve quality deficiencies by collaborating with manufacturing and quality control teams.
Manage quality-related communications with regulatory bodies and internal stakeholders.
Qualifications:
Bachelor’s or master’s degree in Pharmaceutical Sciences.
Minimum 10 years in the pharmaceutical industry, including 3+ years in team management, and a proven track record of successfully managing FDA audits and engaging with global regulatory authorities like EMA and WHO.
Strong knowledge of FDA regulations, cGMP standards, and global pharmaceutical quality systems.
Proficiency in English Language is a must.
Proficiency in Excel for data analysis, Word for report writing, and PowerPoint for presentations.
FDA Certificate is preferable
Experience with global regulatory authorities beyond FDA (EMA, WHO, etc.) is a plus.
