. 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.
• 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.