Merin Thomas
Cork
Summary
Detail-oriented Pharmaceutical Regulatory Affairs graduate with an MSc (NFQ Level 9) and hands-on experience in GMP-regulated manufacturing. Supported compliance with regulatory and quality standards through effective documentation and process monitoring. Drove continuous improvement initiatives and enhanced operational efficiency in sterile production.
Overview
5
5
years of professional experience
1
1
Certification
Work History
Product Builder
Boston Scientific
Cork
09.2025 - Current
- Supported high-volume manufacturing of complex medical devices in GMP-regulated cleanroom environments, ensuring compliance with safety and quality standards
- Operate and troubleshoot automated and semi-automated production equipment
- Perform in-process inspections and monitor process performance to ensure product quality
- Maintain accurate GDP-compliant documentation (batch records, quality logs)
- Collaborated cross-functionally to achieve production KPIs and implement continuous improvement initiatives, enhancing operational effectiveness
- Contributed to problem-solving activities and investigated process deviations, facilitating resolution and maintaining product integrity
GMP Operative
Bidvest Noonan – MSD
Carlow,
09.2024 - 09.2025
- Maintained sterile manufacturing environments, ensuring compliance with GMP and SOP requirements to uphold product integrity
- Executed cleaning validation procedures, ensuring environmental control standards met regulatory requirements
- Ensured audit readiness through accurate completion of logbooks and documentation
- Supported adherence to Safety, Health & Environmental (SHE) standards, fostering a safe operational culture
- Demonstrated strong attention to detail in regulated production environments
Clinical Pharmacist
Airport Dental Clinic
Kerala
02.2022 - 02.2023
- Utilized data-driven decision-making to enhance medication therapy and improve patient outcomes
- Identified and addressed drug interactions to increase treatment safety and effectiveness
- Reviewed patient medication histories to ensure safety and effectiveness.
- Consulted with dental professionals on medication management for oral health treatments.
- Provided patient education on medication usage and potential side effects.
Drug Safety Associate
Wissen Infotech - IQVIA
Kerala
03.2021 - 01.2022
- Processed adverse event (AE/SAE) reports ensuring compliance with global regulatory standards to maintain safety and integrity of drug information
- Performed data analysis, MedDRA coding, and quality review of safety cases to enhance accuracy of safety data reporting
- Supported investigation workflows through thorough case assessment and reconciliation to facilitate timely resolution of safety concerns
- Ensured data integrity, accuracy, and timely reporting
Education
Master of Science - Pharmaceutical Regulatory Affairs
South East Technological University
Carlow, Ireland09-2024
Doctor of Pharmacy -
Swamy Vivekananda College of Pharmacy
India01-2020
Skills
- Manufacturing & Engineering: GMP Manufacturing, Cleanroom Operations, Process Monitoring, Equipment Operation
- Quality & Compliance: GMP, GLP, GCP, GDP, Audit Readiness, Data Integrity, Regulatory Compliance (EU/FDA)
- Continuous Improvement: Root Cause Analysis, Deviation Support, CAPA Awareness, Process Improvement
- Process validation
- Documentation Systems: SOPs, Batch Records (MBR/eBR awareness), Logbooks, LIMS exposure
- Data & Tools: Data Analysis, MS Excel, Documentation Control Systems
- Safety: Strong SHE compliance, Risk Awareness, Controlled Environments
Certification
- Foundations of GMP & Quality Risk Management, Online certification, MSD
- Chemical handling Certificate
- Registered Pharmacist, Pharmacy Council of the State of Kerala, India, 06/21/23
References
Available upon request.
Projects
- Thesis dissertation on Impact of Misleading Advertisements on Health Care Product (probiotics) and Regulatory Protocols for Publishing Advertisements in Ireland, MSc in Pharmaceutical Regulatory Affairs, SETU- Carlow, 2023-2024
- A study on safety and efficacy of Biguanide with Sulfonylureas in Type-II Diabetes Mellitus patients, Internship, Swamy Vivekananda College of Pharmacy, India, 2018-2019
Publications
A study on safety and efficacy of Biguanide with Sulfonylureas in Type-II Diabetes Mellitus patients, International Research Journal of Pharmaceutical and Bioscience Sciences, 12/2020, 5, 6
Languages
English,Malayalam,Tamil,
Timeline
Product Builder
Boston Scientific
09.2025 - Current
GMP Operative
Bidvest Noonan – MSD
09.2024 - 09.2025
Clinical Pharmacist
Airport Dental Clinic
02.2022 - 02.2023
Drug Safety Associate
Wissen Infotech - IQVIA
03.2021 - 01.2022
Master of Science - Pharmaceutical Regulatory Affairs
South East Technological University
Doctor of Pharmacy -
Swamy Vivekananda College of Pharmacy