Jini Paul
Limerick,Ireland
Summary
Results-driven professional with expertise in pharmaceutical quality systems and analytical techniques. Experienced in GMP, GDP, and GLP compliance, with a strong background in CAPA processes, root cause analysis, and audit readiness. Skilled in laboratory methods such as HPLC, GC, and TOC analysis. Knowledgeable in ISO 5-8 cleanroom operations, cleaning validation, and contamination control, ensuring compliance with SOPs and promoting continuous improvement in regulated environments.
Overview
5
5
years of professional experience
6
6
years of post-secondary education
Work history
Clean Room Technician
Regeneron Pharmaceutical Company
Limerick, Ireland
04.2025 - Current
- Maintain GMP-compliant cleanroom environments supporting biologics manufacturing.
- Perform cleaning validation and sterilisation activities using approved pharmaceutical cleaning agents.
- Support batch traceability through MES and electronic logbook systems.
- Participate in deviation investigations and CAPA implementation.
- Ensure compliance with GMP, GDP and EHS requirements.
- Collaborate with QA, QC Validation and Manufacturing teams.
QC Assistant
Green Valley Beverages
Ernakulam, Kerala, Indian
09.2022 - 05.2023
- Executed routine sampling of products, maintained high standards of output quality.
- Provided technical support to the QC team, enhancing overall productivity.
- Followed company SOPs strictly, maintaining uniformity in testing procedures.
- Assisted in microbial and chemical testing.
- Maintained laboratory instruments and calibration records.
QA Trainee
Kerala Enviro Infrastructure Limited
Ernakulam, Kerala, India
06.2021 - 05.2022
- Maintained accurate laboratory documentation and testing records for quality assurance and traceability.
- Ensured compliance with industry standards through meticulous quality control checks.
- Performed BOD, COD, TCLP and heavy metal analysis.
- Conducted wastewater and treated water analysis to ensure compliance with environmental regulations.
- Conducted environmental compliance monitoring.
- Collaborated with team members to achieve project milestones and enhance overall quality of results.
Education
Master of Science - Pharmaceutical Business and Technology
Griffith College
Dublin, Ireland 09.2023 - 11.2024
Master of Science - Chemistry
Karunya Institute of Technology and Sciences
Tamil Nadu, India 07.2019 - 05.2021
Bachelor of Science - Industiral Chemistry
T.M Jacob Memorial Government College
Kerala, India 08.2016 - 05.2019
Skills
Manufacturing and Cleanroom Operations
- ISO 5-8 Cleanroom Operations
- Cleaning Validation
- GMP
- GLP
- GDP
- Pharmaceutical Quality Systems
- SOP Compliance
- Audits Readiness
Deviation Management
- CAPA
- Root Cause Analysis
- Contamination Control
- Batch Traceability
- CIP/SIP
- VHP Sterilisation
- Laboratory and Analytical Skills
- HPLC
- GC
AAS
- UV-Visible Spectroscopy
- IR Spectroscopy
- TOC Analysis
- pH and Conductivity Testing
- BOD and COD Analysis
- TCLP Testing
- MES Documentation
References
References available upon request.
Timeline
Clean Room Technician
Regeneron Pharmaceutical Company
04.2025 - Current
Master of Science - Pharmaceutical Business and Technology
Griffith College
09.2023 - 11.2024
QC Assistant
Green Valley Beverages
09.2022 - 05.2023
QA Trainee
Kerala Enviro Infrastructure Limited
06.2021 - 05.2022
Master of Science - Chemistry
Karunya Institute of Technology and Sciences
07.2019 - 05.2021
Bachelor of Science - Industiral Chemistry
T.M Jacob Memorial Government College
08.2016 - 05.2019