Sarang Patil

Executive @Emcure Pharmaceuticals Limited

Pune, IN

Managing QMS documentation including SOPs, policies, and records.Handling Change Control, Deviations, OOS/OOT, and CAPA with effective root cause analysis.Coordinating internal audits and supporting regulatory inspections (USFDA, MHRA, WHO, TGA).Conducting risk assessments (FMEA, HACCP) to identify and mitigate product quality risks.Delivering training sessions on SOPs and compliance to strengthen quality culture.Driving continuous improvement initiatives (Kaizen, 5S, Lean Six Sigma).Monitoring KPIs to ensure timely closure of deviations and CAPA effectiveness.Skills & Tools:QMS, cGMP, ISO 9001, ICH Q10, WHO TRS, Documentation Control, Risk Assessment, Audit Handling, Regulatory Compliance, Continuous Improvement.

Singhania University

Masters of science Msc

North Maharashtra University

Bachloer of science