NITIN LANDAGE

Experience

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  Centre for Cellular and Molecular Biology

  Dec 2014 - Nov 2015

  Junior Research Fellow

  Cloning and expression of proteins in E.coli.DNA sequencing, SDS-PAGE, DNA RNA isolation.

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  BioGenomics Ltd.

  Mar 2016 - Jun 2017

  Quality Assurance Junior Executive

  Preparation, training on Quality Assurance General SOPs.Review of in-process and finished product (DS, DP) standard testing procedures.Support in preparation of protocol for analytical method qualification, and report review. Review of Stability protocol, stability Schedule, summary review and data trending.Support in creation of process validation, cleaning validation protocol and participation in execution activity.Preparation of annual product quality review (APQR).Handling of change control, deviation, incidence investigation, and compliance thereof through CAPA and risk assessment. Coordination with cross functional teams from R&D, process development and production for batch manufacturing record preparation and review.Responsible for the technology transfer activity and coordination thereof.Gap analysis of technical documents like Master Manufacturing Formula and Method of analysis for various therapeutic and non-therapeutic products.IPQA activity for Upstream and Downstream process, line clearance. Show less

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  Vita Scientia Globus Pvt Ltd

  Jun 2017 - Jul 2018

  Executive CSV

  Reviewing/authorizing documents related to Computerized System Validation.Creation of Validation Plan based on risk assessment, GxP assessment of the system.Define risk-based strategies for the validation of the systems, which includes but not limited to validation methodologies, testing activities, and documentation.Develop and review computer system validation deliverables for accuracy, consistency, clarity and completeness.Ensuring the compliance of computerized systems to regulatory requirements, including but not limited to 21 CFR Part 11 and other applicable regulation. Show less

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  DK BIOPHARMA PVT LTD

  Aug 2018 - Sept 2022

  Involved in project design and review of Upstream and downstream processes, process vessel and process instruments, clean and black utilities, HVAC, clean room design, purified water generation and distribution, Process piping.Supervision of new facility development activity, ensuring timely completion of target in liaison with third party vendors and in-house cross functional department. Supervision and coordination of project activities to meet timeline.Validation master plan (VMP)Equipment Qualification document URS, DQ, IQ, OQ, PQ , review and implementation.Participation in FAT for process machinery, equipment etc.Conducting HVAC and area qualification, Purified water qualification (Protocol Preparation, data analysis and report preparation)Review and implementation of Process automation document. Show less

  • Assistant Manager-Quality Assurance

    Nov 2020 - Sept 2022

  • Senior Executive Quality Assurance

    Aug 2018 - Oct 2020
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  MSD India

  Sept 2022 - now

  Manager