Hire Dr. Hemant Mondkar, a pharma consultant specializing in FDA Inspections 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: Dr. Hemant Mondkar is a pharmaceutical auditor and quality consultant with 30 years of experience in corporate, operational, and R&D quality, including 24 years in managerial positions. He has held senior quality assurance roles with Teva, Fulford, Burroughs Wellcome, and Rhone-Poulenc. His expertise includes GMP audits, third party GMP audits, supplier qualification, FDA inspection readiness, quality assurance, quality management systems, GMP compliance, and training. His auditing experience covers API and excipient manufacturers, drug product facilities, formulation R&D, CROs, contract testing laboratories, and distribution centers. He has led sites through US FDA and WHO inspections and advises organizations on audit remediation and quality system improvements. - Show More
Hemant supports FDA inspection readiness through quality oversight, compliance assessments, and preparation of manufacturing teams for regulatory scrutiny. His experience includes leading a site through a US FDA inspection in March 2019 with no Form 483 observations and supporting corporate pre-approval inspection assessments. He draws on this background to help organizations identify quality gaps and prioritize preparation activities.
Hemant conducts GMP audits of API, excipient, and drug product manufacturers, formulation R&D facilities, contract testing laboratories, and contract manufacturing sites. His experience includes assessments against US FDA requirements, ICH Q7, EU GMP, and other international standards. He helps organizations identify compliance gaps and provides guidance on remediation plans and closure of audit recommendations.
Hemant helps pharmaceutical organizations assess and strengthen GMP compliance across manufacturing, R&D, laboratory, and outsourced operations. His background includes audits against US FDA, EU GMP, ICH Q7, Health Canada, and TGA requirements. He advises auditees on remediation plans and supports follow-up on audit recommendations to address identified deficiencies.
Hemant delivers training on pharmaceutical audits and compliance for quality and operational teams. His experience includes conducting programs at internal and external seminars, supported by formal training in leadership, management, and trainer development. He draws on practical auditing experience to help participants understand audit expectations, recognize compliance gaps, and improve their approach to quality responsibilities.
Hemant provides quality assurance support based on senior leadership experience across corporate, operational, and R&D quality functions. His previous responsibilities include directing QA teams, overseeing contract manufacturing audits, supporting regulatory inspections, and ensuring closure of audit recommendations. He helps organizations strengthen quality oversight of internal operations and external manufacturing partners.
Hemant supports pharmaceutical quality system implementation and compliance assessment. His experience combines quality leadership, corporate risk assessment audits, and remediation guidance across manufacturing and research operations. He helps organizations review their quality practices, identify system gaps, and plan improvements informed by audit findings and operational requirements.
Hemant supports supplier qualification through audits of API and excipient vendors, contract manufacturers, and pharmaceutical packaging component suppliers. His experience includes vendor audits in India and China, supplier due diligence in the United Kingdom, and recurring assessments under vendor quality surveillance programs. He helps pharmaceutical companies evaluate supplier quality practices and identify areas requiring follow-up.
Hemant provides third party GMP audits for pharmaceutical companies and consulting organizations. His consulting assignments include API and CRAMS manufacturing facilities, clinical supply operations, packaging providers, and distribution services in India and overseas. He brings experience assessing external partners against client requirements and applicable quality standards, helping organizations understand compliance gaps across outsourced operations.
