Vijay Kumar Email & Phone Number

Chapel Hill, Nc, Us

Validation/Quality Analyst in pharmaceutical/Healthcare environment with expertise in Computer system validation, Equipment validation, technical writing and QA testing in FDA regulated environment. Proven knowledge and experience to work in manufacturing, laboratory environment and quality systems regulated under FDA and ICH guidelines.

Brooklyn Park, Minnesota, United States

Demonstrated a high level of expertise in integrating Manufacturing Execution Systems (MES), ensuring smoothcommunication with other IT systems.Played a pivotal role in overseeing Computer System Validation (CSV) activities at Contract ManufacturingOrganization (CMO) sites, ensuring adherence to industry standards and company protocols.Implemented robust measures such as audit trials, regular backups, and stringent data integrity checks, therebyfostering a secure and… Show more Demonstrated a high level of expertise in integrating Manufacturing Execution Systems (MES), ensuring smoothcommunication with other IT systems.Played a pivotal role in overseeing Computer System Validation (CSV) activities at Contract ManufacturingOrganization (CMO) sites, ensuring adherence to industry standards and company protocols.Implemented robust measures such as audit trials, regular backups, and stringent data integrity checks, therebyfostering a secure and compliant data environment.Developed and upheld Standard Operating Procedures (SOPs) for CSV processes, offering clear guidelines forsystem validation and compliance. Developing and executing protocols related with installation, operation and performance qualification, authorizing test scripts for TOC analyzer, Weighing Balances, Densitometer used in QC laboratory. ABL, Vi-Cell, SoloVPE and Wave systems utilized in manufacturing units for various stages of Cell culture and Purification. • Creating and completing workflows for new and existing documents in LEADs (Document Management System). Show less

Salt Lake County, Utah, United States

Performed Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) onessential CSV systems to guarantee adherence to regulatory standards. Proactively identified areas for process improvement, optimizing CSV procedures for enhanced efficiency andeffectiveness.Authorized Installation Qualification (IQ) and Operation Qualification (OQ) Protocols for HVAC, Clean Room, IBC lift, Layering System, Floor Scale and Blending system.Involved… Show more Performed Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) onessential CSV systems to guarantee adherence to regulatory standards. Proactively identified areas for process improvement, optimizing CSV procedures for enhanced efficiency andeffectiveness.Authorized Installation Qualification (IQ) and Operation Qualification (OQ) Protocols for HVAC, Clean Room, IBC lift, Layering System, Floor Scale and Blending system.Involved in Operation Qualification (OQ) of HVAC air handling units with dehumidifier.Involved in Installation Qualification (IQ) and Operation Qualification (OQ) of Floor scale weighing terminal.Supported in generating protocols for Commissioning and Qualification of Clean room HVAC, Building Management System (BMS) systemsCompleted end to end validation of Autoclaves used in microbiology laboratory and manufacturing areas for various load patterns (Equipment load and Liquid load).Performed end to end Performance Qualification of Autoclaves used in Cell Culture and Purification Laboratories.Performed Temperature mapping and SIP by using KAYE Validator AVS.Performed SIP for Buffer Hold tanks, Bioreactors-3000K and 11000K.Support Commissioning and Qualification of Reverse Osmosis (RO) purified water systems, Siemens Building Management System (BMS), Clean room HVAC includes N2 and Air Lines.Authorize Installation Qualification (IQ) and Operation Qualification (OQ) Protocols for HVAC, Clean Room, IBC lift, Layering System, Floor Scale and Blending system. Involve in Operation Qualification (OQ) of HVAC air handling units with dehumidifier. Show less

Branchburg, New Jersey, United States

Drafting protocols for qualification sterilization cycles (Steam-in-place) and (Steam Sanitization) for manufacturing equipment at SAL3 and SAL6.Draw steaming circuits in the P&IDs and Identifying low points and determining locations for placements of biological indicators for sterilization cycle qualification.Perform cycle development studies for autoclaves, qualified bovie dicks testing procedure, empty chamber temperature mapping and loaded chamber temperature mapping for liquids and… Show more Drafting protocols for qualification sterilization cycles (Steam-in-place) and (Steam Sanitization) for manufacturing equipment at SAL3 and SAL6.Draw steaming circuits in the P&IDs and Identifying low points and determining locations for placements of biological indicators for sterilization cycle qualification.Perform cycle development studies for autoclaves, qualified bovie dicks testing procedure, empty chamber temperature mapping and loaded chamber temperature mapping for liquids and parts. Show less

Canonsburg, Pennsylvania, United States

Follow the principles of Software Development Life Cycle (SDLC) and was effective in improving the total quality of the software. Developed and reviewed Validation OQ Summary Report.Author and Reviewed Rollout Strategy for Standalone remediation Project. Author and Edit the Validation plan for Recycle Bin Restrictions for standalone remediation. Reviewed and Edited the Validation Plan for General Use PC’s for the application of GPO throughout Mylan sites.

Hyderabad, Telangana, India

Analyzed benefit requests and secure all necessary data to ensure appropriate implementation based onapplied logic of RxCLAIM pharmacy claim adjudication system.Worked with other cross-functional departments to implement new and maintain existing benefit plans and client pricing in the pharmacy claim adjudication system.Managing with Clinical Pharmacy to implement formulary updates and clinical programs by using AS-400 a main frame application.Update back-end database system by… Show more Analyzed benefit requests and secure all necessary data to ensure appropriate implementation based onapplied logic of RxCLAIM pharmacy claim adjudication system.Worked with other cross-functional departments to implement new and maintain existing benefit plans and client pricing in the pharmacy claim adjudication system.Managing with Clinical Pharmacy to implement formulary updates and clinical programs by using AS-400 a main frame application.Update back-end database system by implementing logistics in AS-400 application, with latest inclusions and exclusions of dosage forms of United States Pharma Market.Performed claim testing to ensure accurate claim adjudication.Ran queries out of the RxCLAIM adjudication system to secure all necessary information to implement plan requests. Show less

Master'S Degree, Master'S In Information Assurance And Technologies

Master'S Degree, Information Technology, 3.6

Bachelor'S Degree, Pharmacy, 3.5