Yogesh Phule

Experience

1. Supplier Quality Assurance

   Ecolab

   Apr 2025 — Present · Pune, IN

   Coordinate and plan ISO9001, and ISO13485 audits for suppliers as well as the follow-up to the action plans resulting from these audits.• Coordinates and plans, in conjunction with the site Global supply chain, Quality Manager, procurement team, RD & E and Internal stakeholders.• Use key product & process metrics to evaluate process effectiveness, identify improvement opportunities/best practices, and drive continuous quality improvement activities.• Provide support by applying manufacturing quality tools including, but not limited to: FMEA, DFMEA, PFMEA, DQ, IQ, OQ, PQ, control plans, process verification/validation plans, equipment qualification, Cpk, Cp, SPC, DOE, process data analysis, and DMAIC.• Develop, implement, and ensure that the supplier conforms to customer, internal, regulatory/legal, and certifying organization requirements.• Lead or support root cause investigation of nonconformities and develop, initiate, or implement corrective actions.• Overall implementation, sustainability of ISO9001, ISO13485 Certification including any applicable customer specific requirements.• Manages the documentation creation, update, and control - Responsible for activities involved in supplier quality assurance.• Prepare and provide written and oral reports, communications and/or presentations to management around the development / status of Audits.• Lead and support quality activities including FMEA, SPC, Internal/External audit support, SCAR, and Corrective & Preventative Actions.• Lead or support root cause investigation of nonconformities and develop, initiate, or implement CAPA/SCAR for improved product quality, using standard root cause tools such as 8D, 5 Why’s, Fishbone Diagrams, and others.• Manage and support activities related to alternate supplier approval and product specification enhancements.

Education

• Savitribai Phule Pune University

  Bachelor of Pharmacy - BPharm

  2011 — 2014

• Pune University

  Master of pharmacy

  2014 — 2016