Summary
Overview
Work History
Education
Skills
Personal Information
Languages
Field Of Interest
Affiliations
References
Timeline
Generic

Keyur Ajudiya

Ahmedabad

Summary

Energetically spearheaded QA initiatives at Baxter Pharmaceuticals, showcasing expertise in Trakewise and exceptional problem-solving skills. Achieved significant improvements in compliance and process efficiency, demonstrating a proactive approach to CAPA and NCR management. Renowned for meticulous attention to detail and a commitment to maintaining the highest standards of quality.

Overview

10
10
years of professional experience

Work History

Associate-II QA

Baxter Pharmaceuticals India Pvt. Ltd.
Ahmedabad
09.2016 - Current
  • Handling of Deviation
  • Handling of Corrective Action & Preventive Action (CAPA)
  • Handling of Non-Conformance (NCR)
  • Initiation of Change Control Management (CCM)
  • Continuous Process Verification (CPV) in Manufacturing and Packing activity
  • Line Clearance for Dispensing/ Mixing/ Filtration/ Filling/ Sterilization Process of Sterile manufacturing process
  • Line Clearance for Visual Inspection / Leak test / Labelling / Blister & Cartoning / Check weighing & carton Label stickering / Carton Printing & final Packing in Packing Process
  • In-Process and Finished Product sample, Retain sample, Stability sample, Shipment sample, Elemental impurity sample - Sampling Activity at Manufacturing/ Packing Stage
  • Review of Batch records
  • Alarm report verification of EMS/BMS
  • Verification of cGMP followance on shop-floor during day to day work
  • Approval of Work Orders/ Preventive Maintenance/ Breakdown maintenance in Maximo software
  • Periodic clean room inspection
  • Periodic Building Inspection
  • Document Issuance
  • Document Closure of BMR, BPR and Standard formats
  • Password control and user access rights review activity
  • Preparation & Revision of Standard Operating Procedures
  • Calibration of Analytical instruments
  • Handling of Incident, change control and deviation
  • Periodic Verification of Logbooks
  • Submission of Completed Logbooks
  • Software's proficiency: Trakewise, Electronic Lab Notebook (ELN), Lab Information Management System (LIMS), SAP, JD Edwards (JDE), Minitab for CPV, Controlled Forms System (CFS), Team Center Unified (TCU)

Officer-QA

Aculife Healthcare Pvt. Ltd.
Sachana, Ahmedabad
03.2016 - 09.2016

Chemist-QA

Vovantis Laboratories Pvt. Ltd.
Ranoli, Vadodara
05.2015 - 02.2016

Education

M.Pharm - Quality Assurance

Gujarat Technological University
05-2015

B.Pharm -

Gujarat Technological University
05-2013

12th Standard -

Gujarat Higher Secondary Education Board
03-2009

10th Standard -

Gujarat Secondary Education Board
03-2007

Skills

  • Trakewise
  • Electronic Lab Notebook (ELN)
  • Lab Information Management System (LIMS)
  • SAP
  • JD Edwards (JDE)
  • Minitab for CPV
  • Controlled Forms System (CFS)
  • Team Center Unified (TCU)

Personal Information

  • Date of Birth: 22/12/91
  • Nationality: Indian
  • Marital Status: Married

Languages

  • English
  • Hindi
  • Gujarati

Field Of Interest

Quality Assurance

Affiliations

  • Ranging Study and Knapp study for Visual Inspection Process Enhancement
  • Simplification of Batch Manufacturing Record and Batch Packing Record

References

  • Mr. Pramod Gupta, Manager-QA, Amneal Pharma, Ahmedabad, 9974397040
  • Dr. T.Y. Pasha, Former Principal, Parul Inst. of Pharmacy and Research, Vadodara, 9825629186

Timeline

Associate-II QA

Baxter Pharmaceuticals India Pvt. Ltd.
09.2016 - Current

Officer-QA

Aculife Healthcare Pvt. Ltd.
03.2016 - 09.2016

Chemist-QA

Vovantis Laboratories Pvt. Ltd.
05.2015 - 02.2016

M.Pharm - Quality Assurance

Gujarat Technological University

B.Pharm -

Gujarat Technological University

12th Standard -

Gujarat Higher Secondary Education Board

10th Standard -

Gujarat Secondary Education Board
Keyur Ajudiya