Dev Dutt Email & Phone Number

Chennai, Tn, In

Chennai

Medical Device domain, IVDKey Responsibilities - Preparation of Technical Documentation- Clinical/Performance Evaluation for EU MDR/IVDR Transition- Gap Analysis, Standard Assessment and Manufacturer assistance to derive Design/Performance and Testing requirements.- Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions.- Managing and leading the Regulatory team for Joint Replacement at HCL Technologies. Hires, trains, supervises, motivates, and develops staff; manages schedules and workflow. Responsibility includes Communications business site located in Heidelberg, Germany.- Defect tracker management - Support Quality System activities including NC/CAPA, Internal Audit, and change control.- Provide regulatory guidance to and interact with cross functional business partners including R&D, Marketing, Quality, Operations, Legal and Compliance.- Manages regulatory project implementation and other development activities.

Dehra Dun Area, India

• Responsibility and authority for leading the manufacturing of ELISA (Immunology), Hematology Products from raw material and its transformation into finished product through direct supervision and leadership of hourly manufacturing and other professionals. • Analyze product copalaints and make recomendations regarding their reportibility & Review product promotional material ,labelling ,batch records and specification sheet.• Coordinate efforts along associated with the preparation of regulatory documents for new products .• Hands on working under Good Clinical Practices (GCP) & Good laboratory practices for protein handling for kit preperation.• Determine requirements applying to treatment ,storage shipment or disposal of potentially hazardous production related waste.• Team member for ISO 13485 & Medical devices -- Quality management systems implementation at Dehradun Plant.• Serve as a technical resource to lead, coordinate and oversee problem solving efforts on manufacturing related failures and implementation of identified corrective actions to ensure expedited completion, resolution and close out of potential product quality, cGMP compliance, and safety issues.• Knowledge on new product development lifecycle Handled a project for new product development of HIV ELISA 4th generation kit .• Act as technical lead to facilitate batch monitoring through evaluation of targeted production outputs of both routine (trend review, Batch Record information) and atypical nature (e.g. Disrepancies, Out of Specifications) and by providing data analysis, trend reviews and summary data to that activity as part of ongoing plant operations.• Lead and facilitate process improvement teams , managing the technical issues that affect the production floor.

Gurgaon, India

Buffer Formulation of all RAPID Medical Devices & ELISA Products .- Medical Devices Manufacturing & Testing . - Carrying out R & D activities at various for all RAPID Medical Devices and ELISA Product divisions.- Quality Assurance documentation control of Manufacturing Unit.- Involved in Quality control Audits (Internal & External ) .- Product Development & Trouble shooting .- Inventory control of various ELISA Recombinants, RAPID Solutions,HRPOs,Positve controls, Chemicals and Packing materials. -Trained on ISO trainings other QA trainings . Extra Activities :-Improved Manufacturing Process using LEAN tools-Lead Project to increase manufacturing capacity of Plant-Grand the production line evolution from a pushed system to a synchronized system -Problem analyze and solving to respect the production planning.