R. JEYAPRAGASH

As a Quality Assurance professional with 12 years of experience in Process validation, Cleaning validation, Equipment qualification, Analytical method validation, Hold time study and Transport validation, I have a proven track record of success in evaluating critical process parameters and critical quality attributes. My expertise includes conducting hold time studies, developing profession write-ups for Quality risk assessment, and managing cross-contamination issues.

With experience working as both a shop floor Quality Assurance (IPQA) and Development Quality Assurance, I have a well-rounded understanding of the entire product life cycle. I am skilled in reviewing Process optimization reports, MFRs, Batch records, and APQRs, as well as conducting analytical raw data reviews, OOS and OOT reviews, and QMS reviews.

As a GMP trainer and experienced Internal auditor, I have successfully navigated major regulatory audits like USFDA, MHRA, ANVISA, EMA, WHO Geneva, Zimbabwe, and am well-versed in addressing regulatory deficiencies. I am also skilled in conducting Product recalls (Mock recalls) and handling market complaints.

Overall, I am a results-driven Quality Assurance professional who thrives in a fast-paced environment and excels at managing multiple projects simultaneously. My analytical skills, attention to detail, and regulatory compliance expertise make me a valuable asset to any organization.

• Formulation, In-Vitro Characterization, Dissolution and Stability Enhancement of Oral Delivery of Nano Self-Emulsifying Powder for Poorly Water Soluble Drug, Journal of Bionanoscience, Vol. 9, 1–10, 2015
• Preparation and Characterization of Chemical Cross-Linked Oral Controlled Release of Atorvastatin Calcium Loaded Ethyl Cellulose Microsphere, Advance Science Engineering and Medicine, Vol. 7, 1-10, 2015
• Dendrimer: A Novel Polymer, International Journal Of Research In Pharmacy and Chemistry, IJRPC 2013, 3(2), 2231-2781