Hire Priyanka Pawar, a pharma consultant specializing in Clinical Studies, Medical Devices and Pharmaceutical Quality. See services offered, experience summary, and connect via apicule.
Based in: India
Willing to work in: Global
Consultant Type: Independent Consultant
Expertise summary: Priyanka Pawar is an experienced pharmaceutical Quality Assurance and Regulatory Affairs professional with more than 14 years of industry experience. Her core expertise includes Quality Management System, Regulatory Filing, Chemistry, Manufacturing and Controls (CMC), Quality Assurance, Deviations, Change Management, Supplier Qualification, Equipment Qualification, and GMP Compliance. She currently manages CAPA, deviations, change controls, investigations, market complaints, and other QMS activities while supporting API and finished-product specifications, CMC documentation, and regulatory requirements for Europe, the USA, WHO, and emerging markets. Her experience also includes APIMF, DMF, CEP and eCTD documentation, supplier-document audits, site-transfer support, equipment qualification, SOP development, and exposure to USFDA, EU, HPRA and TGA audits. - Show More
Priyanka has managed change controls throughout multiple pharmaceutical QA roles. Her experience enables her to support structured change-management processes, including evaluation, documentation, coordination, implementation, and compliance review of changes affecting pharmaceutical operations and quality systems.
Priyanka has direct experience reviewing and compiling CMC documentation for pharmaceutical products, particularly solid dosage forms. Her background in API and finished-product specifications, regulatory documentation, and cross-functional coordination enables her to support the preparation and review of CMC information for regulatory submissions.
Priyanka has extensive experience reviewing and managing pharmaceutical deviations and investigations through Trackwise. She can support organizations in deviation assessment, investigation documentation, identification of appropriate corrective actions, and effective closure within the Quality Management System.
Priyanka brings substantial pharmaceutical Quality Assurance experience across QMS management, IPQA, SOP development, investigations, regulatory compliance, documentation review, and cross-functional coordination with R&D, QC, Production, and other quality functions.
Priyanka has extensive experience managing pharmaceutical Quality Management Systems, including CAPA, deviations, investigations, change controls, market complaints, and trending through Trackwise. She can support organizations in reviewing and strengthening QMS processes, documentation, investigation workflows, and quality-system compliance.
Priyanka supports regulatory filing activities through hands-on experience compiling and reviewing technical documentation, APIMFs, DMFs, CEPs, LOAs, regulatory variations, and eCTD submissions. Her experience covers regulatory requirements for Europe, the USA, WHO, and emerging markets.
