Extensive Global exposure working with India, China, Spain, Italy, Mexico, USA, Canada, Brazil, Turkey, Middle-East covering uniquely the full gamut of Manufacturing, Quality & Regulatory of Starting materials, intermediates, APIs and Drug Products.
Hands on working experience in analytical testing (QC), product / process development, tech transfers, scale-ups, manufacturing, preparations of DMFs / dossiers, regulatory submissions, GMP activities and QMS activities (QA).
Extensive experience with global regulatory strategies, regulatory submissions for CEPs (for APIs) in Europe, DMFs/ANDA (eCTD) in USA and European procedures (DCPs, National procedures) for Drug Products.
Certified ISO 9000 lead auditor, Qualified ICH Q7 auditor from APIC and certified DSM Corporate Operational Auditor with 300+ audits. Successfully lead various authority inspections such as CDSCO India, US-FDA, TGA, EU, Russia, KFDA, Cofepris, ANVISA etc.
Certified GDP (good distribution practices) Responsible Person and Compliance Manager.
Exposure with SAP ERP system as Business Process Expert (BPE) in designing, execution and validation of the Quality Management Module. Successful implementation at 5 Global locations.Appendix A