Quality Assurance Head

Job Description : QA Head Location : Salalah, Oman Qualifications & Experience: · Mpharm (Ph.D. preferred) · Strong knowledge of Good Manufacturing Practices (GMP), regulatory requirements and quality management systems. · Experience with audits, regulatory inspections, and managing CAPA processes. · 30+ years experience Skills: o Excellent leadership and team management skills. o Strong problem-solving and decision-making abilities. o Excellent written and verbal communication skills. o Ability to work under pressure and manage multiple priorities. o o Job Specific Information The Head of Quality Assurance (QA) will lead and manage the overall quality strategy of company, ensuring compliance with all regulatory and industry standards. This role involves oversight of product quality, managing the quality assurance team, and driving continuous improvement processes across all stages of production and distribution. The QA Head will work closely with R&D, production, regulatory affairs, and other departments to ensure the highest quality standards are maintained. Key Responsibilities: · Leadership and Management: o Lead, mentor, and manage the Quality Assurance team, ensuring high performance, continuous development, and alignment with company objectives. o Establish, communicate, and enforce quality assurance policies, procedures, and guidelines. o Develop and maintain a robust quality management system (QMS) to ensure consistent product quality. · Regulatory Compliance: o Ensure the companys compliance with local and international regulatory bodies o Stay current on pharmaceutical regulations and industry standards, making recommendations for compliance changes as needed. o Manage preparation for inspections and audits from regulatory agencies and third-party auditors, ensuring timely and accurate responses to findings. · Quality Control: o Oversee the implementation and management of quality control processes across the production lifecycle. o Ensure that products meet safety, efficacy, and quality standards, including raw material testing, batch release, and final product evaluation. o Develop and oversee validation protocols, ensuring that processes, equipment, and facilities are and maintained. · Continuous Improvement: o Lead efforts for continuous improvement of quality processes, identifying areas for enhancement and efficiency. o Implement corrective and preventive actions (CAPA) to address quality issues. o Promote a culture of quality across the organization and integrate best practices into daily operations. · Documentation and Reporting: o Ensure all QA documentation is accurate, complete, and compliant with regulatory standards (e.g., batch records, SOPs, and CAPA reports). o Provide regular reports on quality performance, trends, and issues to senior management. o Maintain a clear system for product traceability and batch tracking. · Risk Management: o Identify, assess, and manage risks related to product quality, supply chain, and regulatory compliance. o Develop and implement risk mitigation strategies. · Collaboration: o Work cross-functionally with R&D, manufacturing, regulatory affairs, and supply chain teams to ensure the successful launch and continued quality of pharmaceutical products. o Coordinate with external partners, including suppliers and contract manufacturers, to ensure quality standards are met.

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