Valgenesis
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
Auditing and Inspection
Risk Assessment
Good Manufacturing Practices
Quality Management Systems
Cross Functional Collaboration
Validation Master Plan
Commissioning, Qualification and Validation
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
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