LEAD EXPERT

Result oriented & seasoned pharma professional with over 2 decades of rich and diverse exposure in Quality domain of Generic formulations (OSD , Sterile Injectables ) and API. In depth understanding of manufacturing and Quality systems , with excellent auditing skills acquired through performing ample number of audits. During the organizational tenure performed atleast 100 onsite audits covering across geography which includes audits of API, Finished dosage form manufacturers, Contract testing laboratories including distribution centres.

Lead Auditor Certifications Through Irca Approved Courses.

•  Familiar with statutory regulations; EU-GMP vol.4- Part I and 2, CFR Part 211 , ICH Q7 and Schedule M
• Quality risk management as per ICH Q9
• Process validations ; Stage II (PPQ) & Stage III (CPV)
• Cleaning validation including the risk based approach in multi product facilities.
• Acquaintance with computer system validation as per ISPE-GAMP 5