digamber mahadik

Having 18 Yers exeperiance in Quality Management Solid dosage , API , injectable , Development Quality Currently Looking CSV and QC Lab. Compliance across Alkem Lab.Ltd.sites. Strong experience in QC Laboratory system Design harmonization and effective implementition across the sites. Handling Of QC Lab. activities.ANDA stability studies ,AMV,AMT. Auditing and compliance Successful Regulatory Audits ,USFDA,EU,MHRA,TGA,EDQM Handlings QMS activity ,self inspection,Vendor audit,Quality matrix Audit compliance . Day to Day QMS activity ,BMR,BPR,APQR ,PV and CV. Having good exposure in QC Lab. Design ,setup and monitoring the Day to Day activity and budgets. Laboratory and MES software Gap identification and Remidation. Lab.system Gap assessment and remidation,IT controls and as Data integrity SMe.