Qualifications, Skills and Experience

• Minimum Master's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, or a related scientific field. hat is
• Minimum 10 years of experience in QA/QC management, including at least 5 years in a senior management role.
• Proven experience in quality management within the pharmaceutical manufacturing industry.
• Strong knowledge of WHO GMP, EU GMP, cGMP, regulatory compliance, and pharmaceutical quality management systems.
• Experience in regulatory inspections, audits, CAPA, validation, quality risk management, and product release processes.
• Strong leadership, strategic planning, analytical, problem-solving, and stakeholder management skills.
• Excellent communication, organizational, and team management abilities.
• Proficiency in Microsoft Office and quality reporting systems.

Key Responsibilities

• Develop and implement quality policies, strategies, SOPs, and quality management systems in compliance with WHO GMP, EU GMP, and regulatory requirements.
• Oversee QA/QC operations, product quality, batch documentation, and final product release or rejection.
• Lead internal audits, self-inspections, supplier audits, and regulatory inspections, ensuring timely closure of findings and CAPA implementation.
• Manage validation, qualification, quality risk assessments, investigations, deviations, complaints, and product recalls.
• Ensure compliance with cGMP, GDocP, data integrity principles (ALCOA), and applicable statutory requirements.
• Monitor quality performance, compliance trends, departmental KPIs, budgets, and continuous improvement initiatives.
• Lead, train, and develop quality teams while ensuring effective resource planning and departmental performance.
• Coordinate with senior management, regulatory authorities, external auditors, and internal departments on quality and compliance matters.