Hire Amit Sharma, a pharma consultant specializing in 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: Amit Sharma is a pharmaceutical quality assurance professional with over 14 years of experience in manufacturing quality, GMP compliance, and quality management systems. His expertise includes quality assurance, GMP audits, supplier qualification, change management, deviation investigations, and complaints handling. His career includes roles with Universal Pharmaceuticals, HFL Healthcare and Wellness, Indoco Remedies, Rexcin Pharmaceuticals, FDC, and Comed Chemicals. He brings experience reviewing quality documentation, overseeing validation and qualification activities, assessing suppliers, and managing technical agreements. His background also includes participation in US FDA, MHRA, WHO/CDSCO, and other audits, supporting his work in strengthening manufacturing quality systems and documentation practices. - Show More
Amit supports pharmaceutical change management through experience reviewing and approving change controls within quality management systems. His work includes coordination with manufacturing, regulatory, R&D, and technical teams. He helps organizations review proposed changes alongside relevant procedures and quality documentation, supporting controlled implementation and consistent documentation across affected functions.
Amit supports pharmaceutical complaints handling through experience reviewing and approving market complaints, related investigations, and CAPAs. His quality assurance background includes coordination across manufacturing and supporting departments. He helps teams maintain clear complaint records, review investigation findings, and document follow-up actions within the organization’s quality management system.
Amit supports deviation management through review and approval of incidents, deviations, out-of-specification and out-of-trend results, investigations, and associated CAPAs. His experience spans pharmaceutical manufacturing quality systems and cross-functional coordination. He helps teams strengthen investigation records, assess supporting information, and document appropriate corrective and preventive actions.
Amit supports GMP audits through participation in internal audits and external assessments of vendors, suppliers, and laboratories. His background also includes exposure to US FDA, MHRA, WHO/CDSCO, and ISO audits. He helps teams assess quality practices, review supporting records, and follow up on corrective and preventive actions arising from audit findings.
Amit supports pharmaceutical quality assurance through experience reviewing and approving SOPs, batch records, specifications, protocols, validation master plans, and site master files. His responsibilities include oversight of qualification, validation, and calibration documentation. He helps teams strengthen document control and coordinate quality requirements across manufacturing, technical, regulatory, and supporting functions.
Amit supports the implementation and management of pharmaceutical quality management systems. His experience includes review and approval of quality events, CAPAs, investigations, and supporting documentation, alongside management review programs and annual product reviews. He helps organizations maintain consistent quality processes and use quality data to identify opportunities for improvement.
Amit supports supplier qualification through audit-based assessments, qualification document reviews, and evaluation of vendors, suppliers, and laboratories for approval or rejection. His experience includes reviewing annual vendor audit plans and approved vendor lists, as well as preparing and maintaining technical agreements. He helps organizations document supplier decisions and follow up on related CAPAs.
