Krishan Kumar Email & Phone Number

B. Pharmacy graduate with more than 11.2 years of experience in Technology Transfer and manufacturing investigations (QMS).SKILL SET: Performing RCA investigation, impact assessment and CAPA management.  Risk assessment with FMEA approach, review of investigations related to major market complaints and incidents. Performing evaluation for practices harmonization across the sites and providing inputs for smooth and harmonized procedures. Formulation technology transfer of drug products from R&D and other sites. Support sites during regulatory audits and inspections.  Coordination with cross functional teams (site investigation and quality team) and providing assistance for RCA investigations and CAPA management during early phase of investigations. Ensure quality of the write up of the investigation reports as per the expectation of regulatory. Process validation, Alternate Vendor Development, Cost Reduction, SUPAC, Equipment Changes, Commercial Product Remediation, product lifecycle management and Troubleshooting. Execution & Monitoring of Pre Exhibit, Filling batches, validation (PPQ) batches, Verification, Engineering batches and post approval change batches. Technology Transfer activities for products from R&D and site transfer products. Troubleshooting of routine commercial batches manufacturing.  Provide Technical guidance and troubleshooting as and when required. Track-wise related activities like Change controls, action items, Locking of deviations, preparation of investigation and CAPA. Handling of OOS/OOT and deviations related to Exhibits/Validations study batches. Performing initial risk assessment with appropriate justification and to provide appropriate control strategy for risk reduction. Compliance of GXP in formulation development and manufacturing site. Conducting hold time studies for the new products and preparation of Hold time study protocols and reports. Technical discussion with R&D, Plant CFT’s for product development and transfer.  Batch working calculations, Product presentations and process flow chart preparation and review required for  product discussion. Review of Technology transfer dossier and preparing Technology transfer plan. Statistical data evaluation for scale up, exhibit and PPQ batches performing Cp, CpK Calculations, graphical evaluation and comparison of the data.

Listed skills include Technical Services, Microsoft Office, Technology Transfer, Validation, and 2 others.

• 

  Pgims, Rohtak

  Pharmacy