Sunando Roy Choudhury

Experience

• 

  Cipla

  Feb 2008 - Jun 2011

  Quality assurance

   Generation and issuance of validation protocol/report and control of soft and hard copies. Periodic review of all quality functions and procedures for appropriateness and validity Improvement, continuous review and upgrading of existing SOPs, specifications, test methods and work system. To assure that all validations are properly planned, conducted and documented. To assure that appropriate calibration and preventive maintenance of manufacturing equipments and laboratory instruments are conducted as scheduled. Ensure line clearance, overprinting proof checking and other controls related to batch manufacturing and packing. Conducting Unit Operation. Review periodically the records relating to each product and report on compliance standards, problems if any recommended action. Responsible to maintain all necessary controls on starting materials, intermediate products and other in process controls. Review the validation documents for the process and equipment qualifications on compliance standards, problems if any recommended action. Preparation, Execution and Review of Process validation and cleaning validation. Performing Media fill validation and review of the same. Review of Batch manufacturing and packing records. Well known about deviation, change control, FMEA, CAPA and Regulatory affairs. Shop Floor Documentation & record reviewing online. Ensure that goods are produced according to protocols accepted for registration. Critically examine the environment with a view to minimizing product contamination. Retention of records. Worked as a packing and manufacturing IPQA To implement discipline, team work and good working atmosphere in work place. Show less

• 

  Dr. Reddy's Laboratories

  Jul 2011 - now

   Ensure Incidents, OOS and OOT are investigated and necessary correction, corrective and preventive actions are implemented. Carrying of online audits, internal audits and ensures its correction, corrective and preventive actions are taken. External Audits support for documents. Review the validation documents for the process and equipment qualifications on compliance standards, problems if any recommended action. Review periodically the records relating to each product and report on compliance standards, problems if any recommended action. Improvement, continuous review and upgrading of existing SOPs, specifications, test methods and work system. Ensure Implementation of documentation system in the quality assurance, quality control, engineering, warehouse, SHE department and other relevant departments. Preparation of Annual product review report. Shall undergo functional and GMP training as per requirement including online updating of training records. Show less

  • Project Management- New Product Launch

    Jul 2014 - now

  • Asst. Manager

    Jul 2011 - Jun 2014