Shilpy Singh

Experience

• 

  Cipla

  Jun 2009 - Dec 2010

  Regulatory Affairs Officer in Cipla Indore

  Plan and execute all activities necessary for the registration of technology transfer/ site transfer and R & D transfer products. Review of all documents pertaining to product registration, Co-ordination with production, quality control and quality assurance to ensure timely regulatory submission of new products and technology transfer products. Review of BMR, BPR, process validation/reports, Stability protocol and Finished products specification etcs. Maintain the records of submission including theb details of documents submitted. Co-ordination in query response after regulatory submission, Storage ,control and retrieval of dossier and other regulatory and other registered documents registration sample/other documents, to maintain database for tracking . Review of regulatory deficiencies and preparation of response to the queries. Pre audit questionnaire execution. Co-ordination and support in regulatory inspections. Preparation and annual updates,co-ordination in pre and post approval changes. Providing the regular updates on regulatory requirements and guidelines. Providing regulatory updates of pharmacopeial changes. Review and upkeep of technical agreements Also involved in FDA licence activities.Involved in Regulatory Audits Show less

• 

  Piramal Group

  Dec 2010 - Feb 2017

  Senior Manager Regulatory Affairs & Quality Assurance in Piramal Enterprises Limited

  Regulatory Submission  Audit compliance  Handling of Market Complaints  Quality Management System & Trackwise Validation Handling of Change control Deviation, CAPA & Trackwise Handling of Queries after Regulatory submission,  Updation of pharmacoepial changes

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  Piramal Group

  Apr 2021 - now

  • DGM (Deputy General Manager- Project Management & Technology Transfer)

    Apr 2023 - now

  • Chief Manager-Project Management

    May 2021 - now

  • Head -Programme/ Project Management & Technology Transfer

    Apr 2021 - now