Shivaji Mare Email & Phone Number

Jadcherla, Telangana, India

India

Works as QA Site Head which handles all Operational QA activities related to OSD and Injectable.Core team member in various Regulatory Audits and its managementTeam leader for Continuous improvement and Central coordinator for Quality of all formulation Units.Release finished products for distribution in market and Rejects in case of failures.Closely work with R & D, MFG. and Quality control team to provide support for product development and RA team.

Overall responsible as a Site QA Head which handles all Operational QA activities includes Validation (Process and Cleaning), Review and approval of QMS activities like Deviations, Change controls, Out of specifications, and QA documents wrt Regulatory prospective and its timely Closure, Site shift activities(Inter and Intra Group of Shilpa), Approval of Master documents Like BMR/BPR/ Qualification/ SOPs etc. and control of documentation includes Issuance, tracking and reconciliation of BMR/BPR/Quality records etc.Team leader for Investigation and approval of QMS documents like Deviations, Out of specification, Out of trends, Failure investigation .Review and approval of site shift related documents includes receiving from RnD to site, Siteto other site and contract Manufacturing site.Handling of Projects in different Software at Pharma like e-BMR/BPR, e logbook, Track wise, DMS , Shipper label in SAP etc.Handling and control of Shopfloor activities (IPQA).Core team member to face and respond the various Regulatory Audits like USFDA., EU, MHRA, MCC, ANVISA, TGA etc.

Overall responsible for Operational QA wrt Validation, Quality management system, IPQA, Document management, Audit exposure specifically USFDA, MHRA, TGA, Health Canada etc. Core team member to face and respond the various Regulatory Audits like USFDA., EU, MHRA, MCC, ANVISA, W.H.O. etcTeam leader for handling of investgational root cause, appropriate CAPA and tracking. Team leader for Audit and compliance and handling of market complaint.

Team lead of IPQA manufacturing and packing, Core team member of Quality Assurance, Team lead of investgation related to manufacturing of parmaceutical products, Responsible for Audit, Response and Compliance of observations of Regulatory and customer audits at site,• Review, approve and authorize the Batch manufacturing documents, site master file, master validation plan, validation & qualification protocols, validation reports and standard operating procedures and other quality system documentations. Release finished products for distribution in market and Rejects in case of failures.

Worked as Production executive in oral Solid Dosage forms , Online review of batch record, manaufacturing activities, Process Validation and sute transfer activities releated for production.Day to day production activities in manufacturing area and planning of production and manopwer for shift work

Worked in packaging activities of Oral Solid Dosage forms, Day to day planning and execution of pckaging activities. Inprocess checks online and batch document prepartion. manpower planning for packaging activities etc