Vineet Gupta

Experience

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  Alembic Pharmaceuticals Limited

  Aug 2016 - Dec 2019

  Quality Assurance Specialist

  Preparation, compilation and review of Annual Product Quality Review report, standard operating procedure and Management of Technical Agreement. Initiate change control and Handling of deviation investigation.Actively participated in Risk assessment of activity as per requirement. Compliance of various audit conducted in plant (self inspection, internal audit and external audit). OOS, OOT and Market complaint investigation.

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  Lupin India

  Dec 2019 - Aug 2023

  Technology Transfer Specialist

  Design Preparation and review of documents related to manufacturing- Batch Manufacturing records and Bill of material (BOM) for Exhibit and Commercial manufacture of products, Qualification / Validation stability protocols and master formula card (MFC). Handling of change control, Document record management QAMS activities. Execution of site transfer of approved commercial products from one facility to another. Compilation of Batch Data presentation of Scale Up, Exhibit, Process Qualification and Validation Protocols and reports. Handling and preparation of QRM Protocol’s and Reports. Execution and coordination for SAP related activities like loading of masters of semi-finished goods (SFGs). Provide support to internal as well as external customers for the smooth execution of projets and tasks. Comply with all cGMP or any other regulatory requirements, including EH&S requirements. Preparation or technology transfer protocols and reports. Show less

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  Glenmark Pharmaceuticals

  Sept 2023 - Nov 2024

  Technology Transfer Specialist

  Facilitate pilot Trail/Scale-up batches (documentation, support in execution etc.)Monitor and ensure environmental control, area/ equipment/ qualification/ calibration as per pre-determined frequency.Plan and execute scale-up/ optimization batches.Monitor and ensure availability of lab consumables, equipment AMCs etc for smooth functioning of the lab.Support & participate in FAT and/or SAT for new equipment procured for pilot lab.Participate in planning of exhibit/ submission batches.Calculate the batch size according to regulatory requirements, equipment constraints and area feasibility.Check availability and release of API, RM & documents at plants; if unavailable, initiate the procurement along with R&D Sourcing.Review the documents required for exhibit/ submission batches.Execute exhibit/ submission batches by providing relevant technical inputs and troubleshooting, wherever necessary.Provide support and contribute in investigations for any OOS observations during manufacturing/ stability.Provide timely feedback and updates to Team Leader.Review the process validation report and provide relevant recommendations if any.Calculate and propose the intended commercial batch size based on annual sales forecast received from Knowledge Cell/ Decision Support Group.Review the calculations of intended commercial batch size based on current annual sales forecast.Review the site documents prepared for commercial validation against exhibit batch documentation for correctness of process parameters, i.e. Batch Manufacturing Record & Process Performance Qualification Protocol.Monitor and provide technical support during the first 3 commercial launch validation batches to minimize chances of failures.Review the Process Performance Qualification Reports of the commercial launch validation batches vis-à-vis the executed batch records. Show less

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  Concord Biotech Limited

  Nov 2024 - now

  Technology Transfer Specialist