NEHAL KOTIAN

A highly efficient, dynamic professional with over 15 years of experience in the pharmaceutical field specialising in procurement, supply chain management, manufacturing and quality assurance. Proven competence in strategic sourcing, supplier relationship management and driving commercial outcomes in regulated environments. Adept at identifying cost reduction opportunities mitigating supply chain risks and ensuring regulatory compliance. field. Have proven competence in handling the entire gamut of pharmaceutical activities – Production, Quality Assurance, Supply chain management, Research and Development, Purchasing, Regulatory Compliance and Investigation. Strong knowledge and thorough understanding of Sourcing / Sourcing practices, procurement technology, innovation and supplier risk management. Comprehensive knowledge of production processes, validation strategy and methodologies. Extensive knowledge of implementing validation process and techniques for various products. Experienced in quality assurance for investigations in change control, deviations, OOE / OOS, market deviations, document review and approval based on regulatory requirement, approval of standard operating procedures, annual product quality review. Knowledge of preparation and review of product developments reports as per quality by design principles like DOE, process optimization, quality risk management, continued process verification, statistical inferences. Have successfully handled various audits – US FDA, WHO, TGA, UK-MHRA, ANVISA-Brazil. Knowledge of ICH Guidelines, GMP principles and PICs guideline. Possessing a good understanding of the essentials of safety, efficacy and quality. A eagerness to learn and assume responsibility seek out and accepts increased responsibility displays candor approach to work.

• Recruited and trained up a validation team
• Mentored less experienced QA members as to the skills needed

• Procurement
• Production
• Quality Unit operations
• Quality Management system
• SOP and Audit Inspection
• Process Improvement
• Statistical Inferences

• Title: Pharmacy and Procurement Specialist
• Date of Birth: 04/11/1986
• Nationality: Australian