Vikrant Rane Email & Phone Number

Maharashtra, India

Mumbai

Pharma Center of excellence acting as Advisory on Greenfield projects for GxP applications, Infrastructure and Validation.Responsible for Onshore & Offshore delivery models for world leader in Pharma organizations. Supporting as a Validation & compliance lead for worlds top most Pharma, Biopharma clients. Hands on with Program, Transition management and providing guidance to Presale teams; using in-depth understanding of business needs. Leveraging Validation experience and giving guidance to various team across life sciences and manufacturing.

Quality Assurance operations of Injectable unit Auditing for the WHO GMP. Quality Control, In-process control Production, Packaging Department, Stores Department and Maintenance departmentSOP and Documentation ReviewProviding guidance and valuable inputs to factory personnel regarding Quality Systems.Giving technical guidance for Method Validation, SOP updates, BMR/BPR review and overall document control. Dossier preparation for regulatory needs.

- Acted as the contact for QC department and end-users of Applications. - Coordinating and communicating queries related to processes, operations with information technology operations with QC / ARD departments.- Supporting ongoing Validation and testing of the new phase of project.- Monitoring the progress as appropriate within domain of responsibility such as, compliance and audit requirements, and other quality standards.- Attending troubleshooting of system, doing Risk Assessment for such events of the application.

- Successfully implemented Laboratory Information Management System (LabWare LIMS) project. - Reduction of Documentation, Review and Authorization time with productivity enhancement is evident.- Supervised and supported Validation of the LIMS project and its execution.- Served as Trainer of LIMS for Quality Assurance( QA), Quality Control (QC) and Analytical Research Development (ARD) personnel.- Technical and project support for the QA, QC and ARD.- Selected team players to support the next phases of the project.- Supervised Validation and testing of the new phase of projects.- With strong technical background supported GLP requirements for computer based laboratory needs.- Ongoing updates related to monograph changes as well as change control requirements of Computer System Validation.

Masters, Analytical Chemistry

=> LabWare LIMS certified for Administration1, Administration2 & Basics. => LabWare LIMS Stability module training completed.

Post Graduate Diploma In Pharmacovigilance, Pharmacovigilance

Qms Auditor / Lead Auditor Training Course No. A17024, Certified By International Register Of Certificated Auditors (Irca)

Activities and Societies: Successfully completed Bureau Vistas Quality Management Systems Auditor / Lead Auditor Training Course No..

Diploma, Materials Management

B.Sc., Chemistry