QHSE Supervisor
Albaker Group
مجموع سنوات الخبرة :28 years, 9 أشهر
• Regulatory Compliance Excellence:
o Orchestrated successful GMP audits and inspections for pharmaceuticals and medical devices principal companies ensuring 100% compliance with guidelines and contributing to a 100% increase in customer satisfaction.
o Orchestrated successful Pharmacovigilance audits and inspections for pharmaceuticals and medical devices principal companies ensuring 100% compliance with principal company guidelines towards EU Arab GVP regulations.
o Orchestrated and represented successful warehouse and facility inspections by regulatory authorities of Qatar MOPH/MDPD with guidelines and regulatory requirements.
• Quality Management System Implementation: Expert in introduction, training and implementation of Global Standards ISO 9001:2015 & ISO 13485:2015 and Eu Arab Pharmacovigilance, ICH and WHO guidelines towards GMP and pharmacovigilance compliance.
• Pharmacovigilance System Implementation: Introduced and implemented pharmacovigilance systems, aligning with global standards and SDEA agreements, resulting in a 100% improvement in adverse event reporting accuracy and compliance.
• SOP Writing Expertise: Expert in writing SOPs according to global standards like ISO 9001:2015 and ISO 13485:2015, WHO guidelines, EU-Arab Pharmacovigilance, and ICH guidelines, ensuring procedural consistency and compliance.
• QMS Training and Culture Building: Organized and conducted in-house training sessions on QMS policies and procedures, fostering a culture of continuous learning and improving staff compliance.
• Change Control Management Expertise: Managed change control based on CAPA and effectiveness check, ensuring smooth transitions by reduction in process disruptions.
• Crisis and Change Management Leadership: Conducted SWOT analyses for crisis and change management, implementing effective strategies to enhance organizational resilience and reduce response times.
• Risk and Opportunity Management: Identified and managed risks and opportunities, securing necessary approvals for strategic implementation and contributing to improvement in risk mitigation effectiveness.
• Regulatory Compliance Excellence:
o Orchestrated successful GMP audits and inspections for pharmaceuticals and medical devices principal companies ensuring 100% compliance with guidelines and contributing to a 100% increase in customer satisfaction.
o Orchestrated successful Pharmacovigilance audits and inspections for pharmaceuticals and medical devices principal companies ensuring 100% compliance with principal company guidelines towards EU Arab GVP regulations.
o Orchestrated and represented succes• ISO 9001:2015 Certification Attainment: Spearheaded the successful achievement of ISO 9001:2015 certification, showcasing a dedication to quality standards and resulting in a 100% improvement in overall operational efficiency.
• Regulatory Compliance Excellence: Orchestrated and represented NHRA/MOH inspections and principal companies GMP, GDP, GSP, QMS & Pharmacovigilance audits, ensuring 100% compliance with stringent guidelines for pharmaceuticals and medical devices, resulting in zero regulatory violations and contributing to a 70% increase in customer satisfaction.
• Supply Chain Optimization Impact: Streamlined supply chain logistics, optimizing processes, and achieving a 90% reduction in lead times, resulting in improved on-time delivery performance and enhanced customer service.
• Robust CAPA Implementation: Implemented robust Corrective and Preventive Action (CAPA) plans, conducting root cause analyses for deviations and quality complaints, resulting in a 100% decrease in incidents and a 100% improvement in product / service quality.
• Pharmacovigilance System Success: Introduced and implemented pharmacovigilance systems, aligning with global standards and SDEA agreements, resulting in a 100% improvement in adverse event reporting accuracy and compliance.
sful warehouse and facility inspections by regulatory authorities of NHRA Bahrain, Qatar MOPH/MDPD with guidelines and regulatory requirements.