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
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