Nikita Shinde

Experience

1. Senior Compliance Executive

   Equinox Labs

   Oct 2024 — Present

   Regulatory Audits / Certification Audits: Coordinating with Regulatory Authorities for conducting external audits as per schedule for ISO/IEC 17025:2017 (NABL), ISO 9001 (Quality Management System), ISO 14001 (Environmental Management System) and ISO 45001 (EOHS). Maintenance and implementation of all positive related documents, records and various certifications required by third- party or customers.• Internal audits: Planning and conducting internal audits in laboratory. Ensuring affectiveimplementation of CAPA and closure of all observations/nonconformities raised during audit, preparing audit reports.• QA: Conducting Risk Assessment, identifying opportunities for improvement, preparing Internal Quality Check (IQC) Plan, Corrective Action and Preventive Action (CAPA).• Documentation: Implementation, Distribution, Updating and Maintenance of all quality relateddocuments and records, Master and Control copies pertaining to total quality management, QA/QC and regulatory requirements SOPs, Formats, Quality Procedure and Quality Manual etc.• Proficiency Testing & Inter Laboratory Comparison: Preparing PT-ILC Plan, conducting ILC.• NABL Portals: Hands-on experience of handling multiple portals of NABL for all the Branches of the Laboratory. Successfully completed applications like First Accreditation, Onsite Surveillance, Renewalof Accreditation, Desktop Surveillance.• NABL FSSAI Integration- Worked on Quality Documents and scope reviewing for Integratedapplication of NABL, FSSAI, EIC, APEDA, IOPEPC, Tea Board and Spices Board.• INFOLNET Portal: Uploading all the required data on INFOLNET Portal.• CPCB Portal: Documenting and record keeping of all the documents required for the CPCBRecognition of the Lab.

Education

• DY Patil University

  Msc

  2020 — 2022