Summary
Overview
Work History
Education
Interests
Audit Exposure
Additional Information
Declaration
Timeline
Generic

Vijay Lokare

Quality Assurance Executive
Nanded,Maharashtra

Summary

Quality Assurance Executive with over 6 years of successful experience in IPQA, Validation and QMS. Recognized consistently for performance excellence and contributions to success in Pharmaceutical Formulation industry. Committed to excellent superior level of teamwork. Excellent organizational, documentation and observational skills.

Overview

4
4
years of post-secondary education
6
6
years of professional experience

Work History

Quality Assurance Executive

Granules India Limited
Hyderabad, (IPQA,QMS, VALIDATION)
03.2020 - Current
  • Expertise in review of BMR ,BPR and Batch release system.
  • Working as shift IN charge of IPQA team.
  • Responsible for initiation and review of Deviations and Change Controls.
  • Artwork- Check and Verify Artwork Database System.
  • Handling of stability samples tracker for commercial, stability and exhibit batches.
  • Performing Process Validations and Cleaning validation sampling and protocol review.
  • Approving the in house generated label in Nice Application.
  • Performing in Process check and line clearance activities.
  • Approving the batches in Jackson Track and Trace, Optel Application.
  • Ensuring Good Manufacturing and good documentation practices during manufacturing.

Quality Assurance Team Member

Dr Reddy's Laboratories Ltd
Hyderabad
10.2017 - 03.2020
  • Experienced in PAS/X system for online execution activities.
  • Expertise in review of BMR,BPR and Batch release system.
  • Experienced in line clearance activity.
  • Experienced in Process checks activity in packing area.
  • Proof and materials verification before starting of packing operation.
  • To report the Incidences and non nonformance observations.
  • Experienced in Process Validation and Cleaning validation sampling.
  • Participation in Investigation of Market Complaint and sharing of market complaint.
  • Review of PV Batches Protocol and Report
  • Involving in change control and incidence activities in packing area.
  • To collect the reserve, stability and internal communication sample.

Quality Assurance Officer

Lupin Limited
Aurangabad
07.2015 - 10.2017
  • To give line clearance for all stages of manufacturing and packing operations.
  • Expertise in review of BMR BPR and Batch release system.
  • To report deviations, incidences and non conformance observations.
  • To perform sampling of semi-finished product, finished product in packing operation.
  • To carry out in-process checks as per respective BMR in manufacturing on online SCADA software.
  • Assure that all calibration/PMP are properly planned, conducted and documented.
  • To Perform Exhibit Batches Sampling i.e. BU and Stratified Sampling as per ASTM- E2709 & E2810 Statistical Plan.
  • Participate in execution of Process validation in co-ordination with production department.
  • To Maintain the Schedule and Tacking of Hold Time Study.
  • Logging and investigation of IPOOS and IPOOT.

Education

Bachelor of Pharmacy -

Government College of Pharmacy
Aurangabad
07.2011 - 07.2015

Interests

Interested in QMS, Regulatory affairs and Corporate Quality assurance

Audit Exposure

Actively Participated in various audits US-FDA,ANVISA,WHO,Europe,MHRA and various customer audits like MYLAN and STADA.

Additional Information

  • Certified in SAP PP Module in 2017.
  • FMEA Certificate from Quality Hub India (Gov. Reg).

Declaration

I hereby declare that the information given above is true to the best of my knowledge.

Date: Vijay Lokare

Timeline

Quality Assurance Executive

Granules India Limited
03.2020 - Current

Quality Assurance Team Member

Dr Reddy's Laboratories Ltd
10.2017 - 03.2020

Quality Assurance Officer

Lupin Limited
07.2015 - 10.2017

Bachelor of Pharmacy -

Government College of Pharmacy
07.2011 - 07.2015

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Vijay LokareQuality Assurance Executive