Summary
Overview
Work History
Education
Skills
Roles And Responsibilities
Languages
Disclaimer
Areas Of Interest
Personal Information
Timeline
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Gokul A

Harur

Summary

To grow with a leading organization that utilizes my abilities to the fullest, helping me realize and develop my potential. I aspire to contribute effectively as part of a dedicated team and achieve excellence through continuous learning and commitment.

Overview

5
5
years of professional experience

Work History

Executive QA

Crescent R&D Private Limited
Sriperumbudur
09.2024 - Current

Regulatory Approvals: UK MHRA, WHO cGMP

  • Strong knowledge of cGMP and regulatory guidelines.
  • Provide line clearance as per approved SOPs.
  • Monitor overall IPQA activities in manufacturing and packing.
  • Perform in-process checks and online entry of BMR & BPR.
  • Review Batch Manufacturing Records (BMR) and Batch Packing Records (BPR).
  • Release intermediate stages for further processing.
  • Perform AQL for bulk finished products.
  • Execute process validation, packing validation and cleaning validation and collect samples as per approved protocols and prepare validation reports.
  • Conduct Hold Time validation as per protocol requirements.
  • Calibrate IPQA instruments such as balances, disintegration tester, hardness tester, friability apparatus, and maintain documentation.
  • Review calibration records, equipment usage logbooks, and area logbooks.
  • Collection of various stages of samples in manufacturing and packing as per specification and forward to Quality control.
  • Involve in Batch release and Dispatch Activities.
  • Executed qualification activities for tablet coating equipment and tamper-evident systems.

Officer QA

Microlabs Private Limited, Unit 11
Bangalore
11.2022 - 08.2024
  • Regulatory Approvals: USFDA, UK MHRA, TGA

Jr. Executive QA

Archimedis Healthcare Pvt. Ltd.
Sriperumbudur
04.2021 - 10.2022
  • Regulatory Approvals: UK MHRA, WHO cGMP

Education

Bachelor of Pharmacy (B.Pharm) -

Madurai Medical College
Madurai
12-2020

Skills

  • E-Capsule
  • Tandra
  • Incrency
  • DMS
  • Nichelon

Roles And Responsibilities

  • Strong knowledge of cGMP and regulatory guidelines.
  • Provide line clearance as per approved SOPs.
  • Monitor overall IPQA activities in manufacturing and packing.
  • Perform in-process checks and online entry of BMR & BPR.
  • Review Batch Manufacturing Records (BMR) and Batch Packing Records (BPR).
  • Release intermediate stages for further processing.
  • Perform AQL for bulk finished products.
  • Execute process validation, packing validation and cleaning validation and collect samples as per approved protocols and prepare validation reports.
  • Conduct Hold Time validation as per protocol requirements.
  • Calibrate IPQA instruments such as balances, disintegration tester, hardness tester, friability apparatus, and maintain documentation.
  • Review calibration records, equipment usage logbooks, and area logbooks.
  • Collection of various stages of samples in manufacturing and packing as per specification and forward to Quality control.
  • Involve in Batch release and Dispatch Activities.
  • Executed qualification activities for tablet coating equipment and tamper-evident systems.

Languages

  • Tamil
  • English

Disclaimer

I hereby declare that the information provided above is true and correct to the best of my knowledge.

Areas Of Interest

  • Validation
  • Market Complaints
  • IPQA

Personal Information

  • Total Experience: 4 years 8 months
  • Father's Name: Anbumani
  • Mother's Name: Aruna
  • Date of Birth: 16/09/1998
  • Gender: Male
  • Nationality: Indian
  • Marital Status: Single

Timeline

Executive QA

Crescent R&D Private Limited
09.2024 - Current

Officer QA

Microlabs Private Limited, Unit 11
11.2022 - 08.2024

Jr. Executive QA

Archimedis Healthcare Pvt. Ltd.
04.2021 - 10.2022

Bachelor of Pharmacy (B.Pharm) -

Madurai Medical College
Gokul A