狠狠撸

Pune Area, India, Maharashtra India

Director QA at Emcure Pharmaceuticals Limited

Manufacturing (Steriles and Oral solids), QC, Site QA, CQA (5 company multiple sites and 10-15 contract manufacturing sites), Formulation Development, Technical Services, Regulatory Affairs, Technical transfers (Development to sites, Validation/Exhibit batches) for ANDAs and MAs and Stability testing 110 Site to site /Technical Transfers in Europe and India API Vendor management (Qualification and Audits) GMP Compliance (FDA, MHRA, WHO Inspections, Customer audits Regulatory Submission-Product registrations, Query Responses and Compliance (FDA) Desktop Audits (marketing authorizations), variation submissions, Gap Analysis, Due deligence QMS, Deviations, CAPA, Change Management, Docum...