Experience

• 

  Gsk

  Jan 2017 - Jan 2017

  Apprentice regulatory affairs

  ▪ Prepare, Manage or Maintain simple and complex Rx regulatory submissions (e.g., new products, renewals, amendments, pro-forma invoice, vaccine lot release, etc.) in accordance with applicable regulations. ▪ Act as liaison between Regulatory Affairs and other functional areas, Represent Regulatory Affairs in cross-functional Local and Global team meetings. ▪ Work out strategies to maintain progress towards fulfillment of regulatory commitments. ▪ Contribute to local process improvements which have an impact on Regulatory Affairs, Quality Assurance or other departments. ▪ Review and communicate current & emerging regulatory requirements in accordance with DGDA. ▪ Maintain and update various global regulatory databases (e.g. PRION, Renewal tracker, GO tracker, etc.) Pokaż mniej

• 

  Gsk

  Jan 2017 - Jan 2017

  Internship
• 

  Gsk

  Jan 2018 - Jan 2020

  ▪ Monitoring e2e process of Contract Manufacturing Operation of GlaxoSmithKline Bangladesh Ltd (Consumer Division) ▪ Managing Local and Global Suppliers to ensure operational demand and meet supply target aligning SQAC, GSK ▪ Strategic decisions of releasing products according to the supply demand and execution of action plans accordingly. ▪ Contributing to local process improvements which have an impact on marketing, regulatory, quality assurance and other departments. ▪ Contributing to distinct functions of CMO as per GSK standards and act as liaison between CMO & GSK functional stakeholders. ▪ Facilitate New Product Introduction, conducting the necessary Trials and Validation as per the defined acceptance criteria to establish the critical process parameters. Also, liaise with R&D on process related documentation and decision-making purpose. ▪ Facilitating Audits, Facility establishment & Projects initiated by SC function, GSK in contract manufacturing site. ▪ Ensuring timely communication of Quality Alert issues. Co-ordinate and track any remediation deemed necessary. Ensure the LOC (Market QA) is informed as appropriate of any assigned deviations, change controls, audit findings, or complaints which may have impact on product sold in their market. ▪ Sharing expertise and functional knowledge to carry out day to day activities effectively and troubleshooting in production, quality, warehouse functions of CMO. Pokaż mniej ▪ Monitoring e2e process of Contract Manufacturing Operation of GlaxoSmithKline Bangladesh Ltd (Consumer Division) ▪ Managing Local and Global Suppliers to ensure operational demand and meet supply target aligning SQAC, GSK ▪ Strategic decisions of releasing products according to the supply demand and execution of action plans accordingly. ▪ Contributing to local process improvements which have an impact on marketing, regulatory, quality assurance and other departments. ▪ Contributing to distinct functions of CMO as per GSK standards and act as liaison between CMO & GSK functional stakeholders. ▪ Facilitate New Product Introduction, conducting the necessary Trials and Validation as per the defined acceptance criteria to establish the critical process parameters. Also, liaise with R&D on process related documentation and decision-making purpose. ▪ Facilitating Audits, Facility establishment & Projects initiated by SC function, GSK in contract manufacturing site. ▪ Ensuring timely communication of Quality Alert issues. Co-ordinate and track any remediation deemed necessary. Ensure the LOC (Market QA) is informed as appropriate of any assigned deviations, change controls, audit findings, or complaints which may have impact on product sold in their market. ▪ Sharing expertise and functional knowledge to carry out day to day activities effectively and troubleshooting in production, quality, warehouse functions of CMO. Pokaż mniej ▪ Prepare, Manage or Maintain simple and complex Rx regulatory submissions (e.g., new products, renewals, amendments, pro-forma invoice, vaccine lot release, etc.) in accordance with applicable regulations. ▪ Act as liaison between Regulatory Affairs and other functional areas, Represent Regulatory Affairs in cross-functional Local and Global team meetings. ▪ Work out strategies to maintain progress towards fulfillment of regulatory commitments. ▪ Contribute to local process improvements which have an impact on Regulatory Affairs, Quality Assurance or other departments. ▪ Review and communicate current & emerging regulatory requirements in accordance with DGDA. ▪ Maintain and update various global regulatory databases (e.g. PRION, Renewal tracker, GO tracker, etc.) Pokaż mniej

  • Assistant Manager - CM Quality, Supply Chain

    Jan 2020 - Jan 2020

  • Executive - CM Quality, Supply Chain

    Jan 2018 - Jan 2019

  • Executive - Regulatory Affairs

    Jan 2018 - Jan 2018
• 

  Unilever

  Jan 2020 - now

  ▪ Responsible for 100% QMS (Quality Management System) implementation and monitoring of GMP, GDP, GWP and Production Plan compliance at 3P Manufacturing Site as per UCL Standards and Requirements. ▪ Generating new SOPs relevant to Production, Quality & Warehouse for 3P Manufacturing site as per UCL Standards. ▪ Maintain data base & documentation for Deviation, Change Control, CAPA, Audit CAPA, Customer Complaints management, RCA for 3P site. Managing e2e material Rejections and report Finance. ▪ Ensuring Stability Study, APR, QCM, Site reporting (All functions), Quality Plan Compliance, Site KPI Reporting. ▪ Supporting e2e vendor enrollment process, packaging and lab improvements and WH inventory management at 3P. ▪ Facilitating New Product Introduction by conducting necessary Trials and Validations as per defined acceptance criteria. Conducting Internal & External Audits.▪ Leading end to end SAP QM operation, Spring CM, Customer Solution Portal, PCP portal at 3P Manufacturing Site.▪ Ensuring Material Planning is aligning with Demand Planning and providing inputs in Manufacturing and Other Process Improvements at 3P. ▪ Supporting and Coordinating Projects at 3P Mnaufacturing aligning cross-functional teams at site driven by core Supply Chain Function. ▪ Driving savings initiatives of Manufacturing Site and Support Procurement savings initiatives for RMs & PMs at 3P. Pokaż mniej

  • Assistant Manager - Home Care BU & Market Quality Operations (Bangladesh)

    Jan 2025 - now

  • Assistant Manager - GTM Quality, Supply Chain

    Jan 2022 - Jan 2025

  • Assistant Manager - CM Quality, Supply Chain

    Jan 2020 - Jan 2022