Selection of process based on feasibility.Study the process at lab level , Provide the inputs for the process development.Evaluate the design at scale up level .
Dr Reddys Lab, IPDO , Hyderbad
From August 2007
Leads the process expert team to support immediate issues that occur on the shopfloor during manufacturing. Scope of the role is ‘door to door’at the Site, from raw materials all along the steps/line/work centers for a certain production. Main focus is first line support, with main emphasis on batch release in quality, on time, on the short time horizon.
Provide subject matter expertise and fundamental knowledge of function and properties of excipients, APIs and packaging materials for the products manufactured.
Support or lead trouble shooting, related to process issues, liasing with shop floor operators, line management and support functions (e.g. engineering).
Responsible for technical deviation investigation, robust CAPA and relevant follow-up, lead product process related investigations including complaints, OOE, OOS.
Support introduction of new process equipment, reviewing User Requirements and supporting, as SME for process related issues, in the various phases of the investment project, from Initiation to Process Qualification.
Support Product Steward(s) to investigate and resolve recurring deviations and issues to process capability that emerge from data trending and annual batch monitoring.
Qualifications & Certifications
Dr BAMu Auranagabd