Quality Assurance Manager
Maadi, Cairo
Quality Assurance Manager
Maadi, CairoPosted 5 hours ago- 2Viewed
- 0In Consideration
- 2Not Selected
Job Details
Skills And Tools:
Job Description
. Develop, implement, and maintain the company’s Quality Management System (QMS).
• Ensure compliance with regulatory requirements (e.g., FDA, EMA, WHO, ISO) and Good Manufacturing Practices (GMP).
• Establish and monitor key performance indicators (KPIs) for quality metrics.
• Lead and mentor the QA team, providing guidance and professional development.
• Conduct training on quality standards, GMP, and regulatory requirements for staff.
• Plan, conduct, and manage internal audits.
• Prepare for and facilitate regulatory inspections and customer audits.
• Implement corrective and preventive actions (CAPAs) based on audit findings.
• Oversee the preparation, review, and approval of quality documents, including SOPs, protocols, and batch records.
• Ensure proper documentation of deviations, non-conformances, and change controls.
• Review and approve batch records for the release of finished products.
• Monitor manufacturing processes to ensure compliance with quality standards.
• Perform risk assessments and recommend actions to mitigate quality risks.
• Drive continuous improvement initiatives to enhance product quality and operational efficiency.
Job Requirements
• Bachelor’s or master’s degree in pharmacy, Chemistry, Biology, or related field.
• 5+ years of experience in Quality Assurance within the pharmaceutical industry, including leadership roles.
• Strong knowledge of GMP, GLP, and regulatory guidelines (e.g., FDA, EMA, ICH).
• Excellent organizational, leadership, and communication skills.
• Proficiency in quality management software and tools.
• Strong analytical and problem-solving abilities.
• This position may require occasional travel for audits or regulatory inspections.
• The role involves cross-functional collaboration with manufacturing, R&D, and regulatory teams.
• Multinational background is plus.
