Summary
Overview
Work History
Education
Skills
Certification
Software And Tools
Acknowledgement
Projects
Accomplishments
Software
Timeline
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Theja Venugopal

Theja Venugopal

Executive - Downstream Operations
Bangalore

Summary

Emerging Professional with 1 year and 6 months of experience in pharmaceutical Sector. Proficient in Manufacturing operations, Regulatory compliance, Quality Management systems and Commissioning, Qualification and Validation (CQV). Seeking opportunity to deliver value and embrace new challenges.

Overview

2
2
years of professional experience
7
7
years of post-secondary education
2
2
Certifications
3
3
Languages

Work History

Executive, Downstream Manufacturing Operations

Biocon Biologics Limited
Bangalore
03.2022 - 10.2023
  • Managed end-to-end qualification of process equipment and cold rooms.
  • Proficient in 21 CFR Part 11, EU Annex 11, GAMP 5, SDLC, CQV, and V-Model, ensuring compliance with pharmaceutical regulatory frameworks and quality standards.
  • Authored, reviewed, and executed qualification protocols: User Requirement Matrix, Installation and Operational Qualification, Performance Qualification, Risk Assessments, Design Qualification, etc.
  • Utilized ValGenesis for electronic validation lifecycle management.
  • Oversaw QMS elements, initiating and implementing Change Control and CAPA.
  • Qualified Reviewer for checklists and batch manufacturing records.
  • Developed Standard Operating Procedures for department.
  • Managed document control including checklists, logbooks, and BMRs.
  • Familiar with FDA, EU, Health Canada, and other regulatory bodies' guidelines, with a solid understanding of regulatory pathways for pharmaceutical products.

Education

Master of Science - Biochemistry

St. Aloysius College (Autonomous)
Mangalore, Karnataka
08.2019 - 08.2021

Bachelor of Science - Biotechnology, Biochemistry and Genetics

Garden City College
Bangalore, Karnataka
06.2016 - 06.2019

12th - Physics, Chemistry, Biology & Language [Sanskrit]

Chinmaya Vidyalaya
Thrissure, Kerala
05.2015 - 05.2016

10th -

Chinmaya Vidyalaya
Thrissur, Kerala
05.2013 - 05.2014

Skills

    Regulatory Compliance

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Certification

Biocon KGI Certificate Program in Biosciences - Keck Graduate Institute, California, USA & Biocon Academy, Bangalore, Karnataka Certified

Software And Tools

  • MS Office
  • Excel
  • SAP
  • Val genesis
  • Trackwise
  • Procedure Module
  • Success factor (Learning Management system)

Acknowledgement

I hereby declare that all information provided herein is accurate to the best of my knowledge and belief

Projects

Isolation and Molecular Characterization of Microbial Isolate for Bacterial Cellulose Production in Cashew Apple Medium (Master's Thesis)

Accomplishments

  • Biocon Biologics ‘Go Getter Award’ for exceptional and ingenious contribution in meeting functional and organizational goals
  • Alpha Grade ‘O’ (outstanding) and 2nd Rank in M.Sc. Biochemistry

Software

Valgenesis

SAP

TrackWise

MS Office

Excel

Timeline

Executive, Downstream Manufacturing Operations

Biocon Biologics Limited
03.2022 - 10.2023
Lab Scale & Pilot Scale Fermentation Training - Biozeen Certified
12-2021
Biocon KGI Certificate Program in Biosciences - Keck Graduate Institute, California, USA & Biocon Academy, Bangalore, Karnataka Certified
10-2021

Master of Science - Biochemistry

St. Aloysius College (Autonomous)
08.2019 - 08.2021

Bachelor of Science - Biotechnology, Biochemistry and Genetics

Garden City College
06.2016 - 06.2019

12th - Physics, Chemistry, Biology & Language [Sanskrit]

Chinmaya Vidyalaya
05.2015 - 05.2016

10th -

Chinmaya Vidyalaya
05.2013 - 05.2014

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Theja VenugopalExecutive - Downstream Operations