Brajendra Kumar

About Brajendra Kumar

Responsibilities and Experience: QMS Documentation: Handling Change Control…

Experience

1. Executive

   Rusan Pharma Ltd

   Mar 2025 — Present

   Responsibilities and Experience:QMS Documentation: Handling Change Control, Deviations, Failure Investigations, and CAPA in compliance with regulatory and GMP requirements.Executing and monitoring QMS activities through TrackWise and QAMS to ensure timely documentation, closure, and regulatory compliance.Documentation Management: Preparation and revision of SOPs, BMRs, BPRs, and Validation Protocols, Reports through DMS. Review and completion of documents such as BMR, BPR, and ECR, Maintain intermediate, finished goods stock, and recovered solvent records.SAP Operations: Planning of raw materials and packing materials in SAP, creation of product codes in material master, preparation of BOMs and recipes, creation of process order and purchase request, yield confirmation, and stock overview.Production Activities: Handling batch process activity like Layer separation, Distillation, filtration, centrifugation, Drying, Packing and repacking process.Training Coordination: Serving as departmental training coordinator, Prepare training content and upload SOPs in LMS, Ensure completion of departmental trainings assigned to employees.Software Expertise: Proficient in DMS, TRACKWISE,QAMS, LMS, SAP, HMI, PCS.Batch Process & Equipment Handling: Skilled in operating and managing equipment such as Reactors, Centrifuges, Dryers, Filters, Milling Machines, Sifters, Blenders, as well as processes including synthesis, intermediate, purification, concentration, and Lypholization.Audit Preparation & Compliance: Ensure readiness of the production area for regulatory, customer, and internal audits (FDA, WHO, EU, etc.), Maintain GMP compliance across all production processes, documentation, and housekeeping.Review and ensure accuracy, completeness, and traceability of documents such as BMR, BPR, SOP, Logbooks, and Validation reports.

Education

• Dr. A.P.J. Abdul Kalam University

  Msc

• Bundelkhand University

  Bsc

  2013 — 2016

• Dr. A.P.J. Abdul kalam university

  Msc chemistry

• Apj Abdul Kalam University indore

  Master's degree

• Dr A.P.J.Abdul kalam university indore

  Msc

  2017 — 2019

• Dr. A.P.J. Abdul Kalam College of Education, Yusufiya Colony, Parbhani

  Master of Science - MS

  2016

• Bundelkhand University

  Bachelor of Science - BS

  2014 — 2016