Ashok Marathe

Background

About Ashok Marathe

Experience in Quality control, Quality Assurance, Validation and Quality Compliance in pharmaceutical organisations. 15+ years of Experience in different streams of Quality Departments Handling the responsibilities of Commissioning & Qualification,In-process QA,Quality Management System and Validation. Having an experience in commissioning & qualification activities for the new & renovated clean room facilities, equipments & utilities. Having experince in qualifications of Computer system based on GAMP 5 with software life cycle deliverables. Handling of change controls, CAPA, deviations, Risk Analysis, OOS, OOT & Equipment Malfunction. Preparation of Document (SMF, VMP, Quality Manual), Designing of Documentation. Batch Release, Gap analysis, Audit compliance, internal quality audit. Process Assurance (Experience in Quality Assurance Shop floor activities in both manufacturing & packing operations) Qualification of equipment, Area Qualification, Aseptic Process simulation, Sterilization Validation. Validation of utilities such as AHU System, Water System, compressed air, CO2, O2 & Nitrogen gas. Working experience in regulatory approved (USFDA, MHRA, TGA, MCC, ANVISA, EU, WHO,etc) Sterile Formulations like; Injectibles (Liquid, Lyophilized) Ophthalmic, BFS (Blow Fill Seal) Process of complex products like Lupeide Depot, Amphotericin, Spray drying etc.