Yash Kolambe

Experience

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  Pregna International Ltd.

  Sept 2021 - May 2024

  Quality Assurance & Regulatory Affairs

  Professional experience in Quality Assurance & Regulatory Affairs functions in Medical Device Industry. • To represent Quality Assurance department at various external Regulatory & Quality audits such as ISO 9001 : 2015, ISO 13485 : 2016, MDSAP, CE Periodic/recertification audits, customer Audits & Customer Visit. • Responsible to conduct and schedule Internal audit as per the frequency. • Responsible to conduct periodic vendor audits for vendor evaluation as per the schedule. • Preparation of product standard, Product description and summary of products. • Preparation of documents for Internal & Regulatory Audits of quality system as per ISO guidelines. • Preparation & Compilation of documents for renewal of registration in different countries and regulatory authorities. • Deals with In-house non-conformities of components and raw material. • Co-ordination with different departments in plant for quality and regulatory data compilation. • Preparation & review of all components, packaging material, specifications required for production. • Review and approval for artworks as per customer & Regulatory requirement.• Compilation and review of CE Technical Dossiers of products as per IMDR - 2017 & EU MDR 2017/745 • Handling of customer complaints & adverse events along with reporting to the authority. • Responsible for the preparation of documents for CAPA, Change control, Deviations, MRC & Internal Audits. • Application for Manufacturing license, Free sale certificate, Market standing certificate, Loan license, etc. on CDSCO portal. • Responsible for preparation of Protocols and reports for Stability study.• To provide compliance for audit findings closure.• To conduct factory inspection on regular basis. Show less

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  Meril

  Jun 2024 - now

  Sr. Officer - Quality Assurance & Regulatory Affairs