Shakeel is a dedicated Quality Assurance professional with hands-on experience in pharmaceutical quality systems, new product development (NPD), audits, and regulatory compliance. Currently working as a Quality Assurance Officer (NPD & Audit), he supports the development, validation, and lifecycle management of pharmaceutical products while ensuring alignment with international regulatory standards and Good Manufacturing Practices (GMP). His expertise includes providing QA oversight during new product development, reviewing and approving product development reports, protocols, and validation documents, and ensuring compliance with regulatory guidelines such as ICH, FDA, EMA, WHO, and DRAP requirements. He is well-versed in process validation, cleaning validation, method validation, change control, deviation handling, CAPA management, and risk assessment activities. He also contributes to technology transfer activities by ensuring that quality and compliance are integrated from development to commercial manufacturing. In addition to NPD support, he is actively involved in internal audits, vendor audits, and study-related audits, assessing compliance with approved protocols, SOPs, and regulatory expectations. He has experience reviewing analytical data, dissolution profiles, similarity factor (f₂) evaluations, stability studies, and quality documentation to ensure data integrity and scientific robustness. He possesses a strong understanding of analytical techniques such as HPLC and dissolution testing, along with a solid grasp of GLP, GDP, and data integrity principles. With a detail-oriented, risk-based, and compliance-driven approach, he focuses on continuous improvement and inspection readiness. Through effective communication and collaboration with cross-functional teams including R&D, QC, Production, Regulatory Affairs, and external stakeholders, he contributes to maintaining high-quality standards and supporting the delivery of safe and compliant pharmaceutical products.