Urwashi Milan

Experience

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  UNICURE INDIA LTD

  Aug 2014 - Jan 2016

  Quality Assurance Officer

  In Unicure India Ltd. I am appointed to IPQA activities, to ensure any time rediness on the shop floor with respect to regulatory audit, in view to comply the GMP activities, involving in execution of exibit batches, handling and calibration of IPQA instruments.

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  Cosmas Research Lab Ltd

  Feb 2016 - Mar 2017

  Sr. Officer Quality Assurance

  Issuance of all BMR & BPR to production department & retrieval for the same.To issue all logbook and retrieval for the same for all department.Maintained all the records of issuance and retrieval of all document as per current cGMP.To make all formats of QC department as master & issue operational copy to QC department & maintain all the record for the same.To maintained the document room & control all document of QA in documentation room.Performing in process checks (IPQA) at Dispensing, formulation, filling, sealing and visual inspection and ensuring that the Good manufacturing activities are followed. Show less

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  Surya Herbal Limited

  Apr 2017 - Aug 2018

  Quality Assurance Executive

  Preparation of SOPs, Issuance, distribution, Reviewing and controlling GMP Documentation.Issuance of all BMR & BPR to production department & retrieval for the same.To issue all logbook and retrieval for the same for all department.Handling all the In-process quality Assurance activities in manufacturing facility.Reviewing all the GMP documents.Faced FDA and AYUSH audits.Part of Internal audit team and conducted External vendor audit.Handled Installation Qualification IQ, Operational Qualification OQ, Performance Qualification PQ, Requalification RQ of Various key equipment of production.Verification the check points of Batch processing.Self-Inspection findings and corrective actions. Show less

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  BHAGAT AROMATICS LTD

  Aug 2018 - now

  Sr. Executive Quality Assurance

  Handled the Quality Management system (QMS) Change control management: Evaluation, approval and disposition of changes with impact assessment from quality and regulatory prospective.Conducting investigations to identify the possible root cause for any deviations from written procedures, assessing the impact of deviation and Identifying Corrective and Preventive actions to prevent recurrence and occurrence of the deviation.Successfully faced EU- GMP, WHO-GMP, FSSAI , FSSC 22000 audits.Preparation of audit responses, reports and necessary follow-ups on the implementation of corrective and preventive actions within the identified timelines.Expertise in Preparation of high level documents and protocols like Batch manufacturing records, SOPs, Process Validation Protocol , APQR, DMF.To provide cGMP Training & induction training to Operator & new recruit.Handling of Change Controls, Incidents & Product Market Complaints. Show less