Team

25 years experience in Quality operations and remediation work. Worked in various top pharmaceutical companies in middle management Worked with Dr. Reddy’s laboratories, Ranabxy, Granules India Limited, Parke-Davis (India) Limited, Dai-Ichi laboratories and Sangfroid Remedies limited. Having exposure for Testing (Raw materials, Packaging materials, KSMs, Intermediates and Finished dosage units). Risk based qualifications of CROs/CMOs, raw material vendor. QbD based Lifecycle management of Methods and Product and process development. Faced various regulatory audits such as USFDA, MHRA, ANVISA, TGA, PMDA. Remediation activities involving Warning Letter response of Stability management and Quality Control. Driving Site Investigations towards implementation of preventive actions through Design controls for OOS, Incidents and Technology transfer activities.