Experience

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  Ranbaxy

  Aug 2010 - now

  Working in Analytical DepartmentWell versed in generation, maintenance and revision of specifications,STP’s and other documentation systems mainly for for European Union,canada, Australia, South Africa and EmergingMarkets and gain a good insight about the regulatory requirementsof various requlatories agencies and participated on a short, mediumor long-term projects within the FDA regulated industries

  • RESEARCH SCIENTIST

    Aug 2010 - now

  • manger

    Aug 2010 - Mar 2015
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  Sun pharma

  Mar 2014 - now

  Corporate Quality compliance, policies and Training.Content creator: Author and fully manage the lifecycle (development, review, change control, execution, approval, effective status, training activities, revision, obsoleting etc.) of the following global document Global Quality Manual ,Global Policy (GPOLs) o Global Quality Standards and SOPs) Function as the SME on the applicable Health Agency Regulations and best industry practices.Training: Creation of GMP and GxP modules, these Modules were designed considering the requirements of thetarget audience and were developed specifically to cater their job requirements like Data reliability, GMP andimparting training to target AudienceData reliability improvement Program: Assess Data Integrity awareness and knowledge among employees at sites. Develop Data Reliability checklist. Assess the data reliability at 04 FDA manufacturing sites with thesupport of Site Quality/ Operation representative. Propose action plan based on the assessment.Office of Quality and Budgeting :Analysis of regulatory Inspection finding through effective use of the Regulatory Agency Inspection Database (RAID), and continuous feedback for upgrading regional and local quality System.Justification and synthesis of regional and Functional budget proposals to meet corporate and global QA strategic goals in collaboration with finance, Human resource and other key stakeholders. Monitoring the utilisation ofCAPEX and Manpower budget in compliance to approved numbers.Collect the Quality metrics for presentation of data’s in Management review meeting in due coordination with allstakeholders. Follow-up with all stakeholders for compliance to action plans as part of Management review meets Show less

  • Sr. Manager Corporate Quality complaince policies and training

    Aug 2014 - now

  • MANAGER-Corporate Quality GxP training Certification and communication

    Mar 2014 - now