RISHI CHAUBEY

Experience

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  DHANUKA LABORATORY Ltd.

  Feb 2002 - Mar 2006

  Officer (Quality Control)

  Analysis of Raw Material & Intermediate .

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  SYMBIOSIS PHARMACEUTICALS Pvt.Ltd.

  Mar 2006 - Jun 2012

  Senior Officer ( Approved Chemist )

  Analysis of Raw Material , In Process & Finished Product .Preventive Maintenance & Calibration of Instruments in QC.Maintenance of Laboratory Reagents.Planing of Out Side Laboratory Testing Updation of Status LABEL in Quality Control Laboratory.Sampling of RM,PM as per requirementAnalysis of Packing MaterialCOA Preparation for RM , PM & FP

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  Ranbaxy Laboratories Ltd.

  Jun 2012 - Nov 2013

  Sr. Officer

  REGULATORY AUDIT FACED FOR QUALITY COMPLIANCE OF ANVISA , TGA , GERMAN AUDIT .

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  NUCLOTEC REMEDIES Pvt Ltd

  Nov 2013 - now

  QA Manager

  1.PREPARATION AND IMPLEMENTATION OF QUALITY ASSURANCE SYSTEM PROCEDURES IN ALL THE OPERATIONAL AREAS & ONLINE MONITORING OF ACTIVITIES IN FACILITIES TO ENSURE COMPLIANCE WITH THE CGMP REQUIREMENTS. 2.REVIEW & APPROVAL OF SPECIFICATIONS (RAW MATERIAL, PACKING MATERIAL, INPROCESS AND FINISHED PRODUCT). 3.REVIEW AND RELEASE OF BATCH MANUFACTURING RECORD AND BATCH PACKING RECORD THROUGH SAP-QUALITY MODULE FOR LOCAL AS WELL AS EXPORT MARKET. 4.REVIEW OF DOCUMENTATION IN CO-ORDINATION WITH REGULATORY AFFAIRS DEPARTMENT FOR ANDA SUBMISSION. 5.EXECUTION OF DQ/IQ/OQ/PQ OF CRITICAL EQUIPMENTS AND UTILITIES. 6.HANDLING OF MARKET COMPLAINTS, CHANGE CONTROLS, DEVIATIONS, INCIDENT REPORTS, ANNUAL PRODUCT REVIEW AND CAPA. 7.TO REVIEW AND APPROVE STABILITY PROTOCOL AND REPORTS FOR NEW AND EXISTING PRODUCTS. 8.DEVELOPMENT & QUALIFICATION OF VENDOR FOR ACTIVE PHARMACEUTICAL INGREDIENTS AND EXCIPIENTS BY CONDUCTING VENDOR AUDITS. 9.FILING OF PRODUCTS FOR PROCUREMENT OF LICENSES, COPP, GMP CERTIFICATE FOR DOMESTIC AS WELL AS EXPORT IN CO-ORDINATION WITH STATE FDA. 10.HANDLE COMPLAINTS, RECALLS, COUNTERFEITS & PRODUCT TAMPERING AS PER THE GUIDELINES IN CORPORATE QA MANUAL. 11.APPROVAL OF ARTWORK FOR NEW PRODUCTS MANUFACTURED AT SITE. REVIEW AND APPROVAL OF CHANGES TO PRODUCT AND PROCESSES (INCLUDING LABELING) FROM A RA PERSPECTIVE FOR LOCAL AS WELL AS EXPORT MARKET. 12.HANDLING OF TRAINING GMP, SITE DEPARTMENTAL SOPS, QAPS FOR ALL THE EMPLOYEES AND TO CONFERS WITH PROFESSIONAL STAFF AND MANAGERS ON INSPECTION AND AUDIT FINDINGS, ACTIVELY INVOLVED IN RECOMMENDING ACTIONS AS SOLUTIONS TO PROBLEMS IDENTIFIED THROUGH THE AUDIT PROCESS, AND CREATES RESPONSE TO REGULATORY COMPLIANCE ISSUES. 13.DEVELOPMENT & IMPLEMENTATION OF PROTOCOLS FOR PERSPECTIVE-RETROSPECTIVE AND WATER SYSTEM VALIDATION. Show less