Sulthan Mona

About Sulthan Mona

With over Ten years of experience in pharmaceutical and chemical manufacturing, I…

Experience

1. Process Engineer

   Dr. Reddy's Laboratories

   Nov 2023 — Present · Hyderabad, IN

   1.Ensure process robustness on a continual basis (Continuous monitoring of batches, trends etc.) 2.Ensure adequate investigation for incidents/OOS/OOTs/ Process related incidents with appropriate CAPA.3.Report preparation & writing. 4.As a part of Plant process safety team, conduct & participate in the process Hazard Analysis (PHA)/ Hazard evaluations of the existing process new processes to provide mitigation measures. Also participate MOC & PSSR activities on site.5.To provide support in implementation of the actions arising.6.Quality by preparing, interpret and implement actions arising out of CPV/APQRs/ARRs7.Production capacity by de-bottlenecking or reduction in batch cycle times8.Actual Yields against the budgeted yields and product cost9.Solvent recovery10.Technology that will improve process robustness, safety or productivity.11. Involvement in product mapping of the site transfer products.(Equipment mapping and line modifications)12.Preparation of PFD and block diagrams. 13.Preliminary Capacity sheet preparation (Bottleneck identification etc.)14.Document during trail and validations – Preparation of Quality Risk Assessment (QRA), Equipment suitability, Utility assessment, Surface area calculation for equipment etc.15. Review of Protocol, Report and BPR.16. PSSR and preliminary PHAs.17. Batch monitoring for trail and Validation.18. Automation and Mechanical advancements:19. Involve in coordinating with vendors to adopt new automation Philosophy to running plant and absorption.Coordinating in activities like replacement of major/minor equipment in the plants as a part of capacity expansion.

Skills

• Scale Up
• Pharmaceutical Industry
• Validation