TOM JOSE
Dublin
Summary
Quality Assurance Officer experienced in quality assurance, quality control, and GMP manufacturing within medical devices and chemical processes. Delivered effective management of QMS, CAPA, deviations, and non-conformances while ensuring regulatory compliance through thorough audits and SOP development. Knowledgeable in ISO 9001, ISO 13485, ISO 14001, and ISO 45001, contributing to raw material testing, SDS review, and COA evaluation.
Work Authorization: Stamp 4 – Eligible to work in Ireland without employment permit sponsorship.
Overview
5
5
years of professional experience
Work History
Quality Assurance Specialist
EVA-TEC DAC
BALLBRIGGAN BUSINESS PARK,DUBLIN, IRELAND
05.2025 - Current
- Conducted deviation, non-conformance, root-cause, and CAPA investigations.
- Performed regular internal quality audits to identify improvement areas and support compliance.
- Ensured accuracy, traceability, and adherence to good documentation practices in production and quality documents.
- Resolved customer complaints regarding product quality, implementing corrective actions to enhance satisfaction.
- Maintained controlled quality documents and standard operating procedures.
- Facilitated ISO 9001, ISO 14001, and ISO 45001 audit follow-up by tracking findings and ensuring closure.
- Provided technical guidance to other departments on quality assurance matters.
- Reviewed production records to support EVA-TEC DAC quality compliance.
- Trained professionals in quality assurance methods and techniques onsite and remotely.
- Supported chemical safety, environmental, and occupational health and safety compliance activities.
- Calibrated, validated, or maintained laboratory equipment.
Production Support Specialist
EVA-TEC DAC
BALLBRIGGAN BUSINESS PARK,DUBLIN, IRELAND
12.2024 - 05.2025
- Operated automated cylindrical batch-mixing tank system for industrial glue production, programmed and calibrated multi-point load cell modules, and fixed PLC logic and HMI screen issues for monitoring, diagnostics, and safety.
- Directed warehouse logistics using company certification to operate counterbalance forklifts, handled heavy chemical drums, staged bulk raw materials, and loaded palletized finished goods for shipping.
- Supported packaging lines with gravity-feed filling systems and pneumatic lid-pressing equipment, assisting warehouse staff and forklift operators with safe inventory handling and shipping.
- Supervised QC team and reviewed QC test results to confirm all finished products met customer specifications.
- Trained operators on Eva-Tec DAC safety rules, quality checks, and standard procedures to enhance compliance.
- Reviewed batch manufacturing records after each production and assisted operators with clean-in-place tasks.
- Inspected products at Eva-Tec DAC, corrected defects, and supported quality standards.
Quality Control Inspector(Packaging
ADVANT MEDICAL
GALWAY, IRELAND
07.2024 - 12.2024
- Verified incoming materials against Advant Medical quality standards and product requirements.
- Conducted thorough inspections to ensure compliance with quality standards.
- Communicated quality issues to production teams and supervisors for prompt resolution.
- Ensured inspection area was tidy and organized and maintained calibrated measurement tools.
Quality Assurance Inspector
BIOTEC HEALTH CARE PVT LIMITED
ROSCOMMON, IRELAND
09.2023 - 07.2024
- Tracked and documented nonconformances in TrackWise, ensuring follow-up and adherence to QMS procedures.
- Assisted with nonconformance investigations, root cause analysis, and CAPA documentation.
- Monitored nonconformance records and helped drive timely closure of quality issues per internal procedures.
- Supported ISO 13485 audits by reviewing quality records, preparing audit documentation, and checking compliance with QMS requirements.
- Assisted with internal and external audit preparation through document retrieval, record verification, and follow-up on audit findings.
- Supported HPRA regulatory inspections by preparing required quality documentation and assisting with compliance record reviews.
- Addressed audit observations and nonconformances by maintaining supporting evidence and facilitating corrective actions.
- Maintained documentation traceability and record control to ensure compliance with medical device quality and regulatory requirements.
Manufacturing Specialist
BIOTEC HEALTH CARE PVT LIMITED
ROSCOMMON, IRELAND
06.2023 - 08.2023
- Performed in-process and final product inspections using microscopes and precision measuring equipment to verify conformity and identify defects.
- Configured and operated DAC/MLC equipment, tuning dioptres, radius, air cut, and operating speed to ensure compliance with manufacturing specifications.
- Coordinated machine calibration, troubleshooting, process monitoring, and quality reporting to enhance product consistency and support manufacturing efficiency.
- Maintained DHRs and manufacturing documentation in compliance with established procedures and applicable regulatory requirements, including 21 CFR 820.184.
- Prepared manufacturing records, process documentation, and quality evidence to ensure ISO 13485 audit readiness and support HPRA inspections.
- Applied approved manufacturing procedures, EU GMP/cGMP principles, PPE requirements, and GDP standards to maintain product quality and workplace safety.
Quality Intern
SHINE STAR PHARMA HOSUR
HOSUR, INDIA
11.2021 - 03.2022
- Performed physical and quality checks for pharmaceutical materials and finished products.
- Executed in-process inspections and monitored manufacturing activity for compliance.
- Investigated root causes and executed CAPA tasks to address quality concerns.
- Assisted in tablet manufacturing with coating and friability testing to ensure product quality.
- Maintained equipment through calibration and completed quality records.
- Supported raw-material testing and compared certificates of analysis with approved specifications.
Education
MSC IN PHARMACEUTICAL BUSINESS AND TECHNOLOGY - Pharmaceutical Sciences
GRIFFITH COLLEGE DUBLIN
DUBLIN ,IRELAND09-2023
Bachelor of Science - Pharmacy
PUSHPAGIRI COLLEGE OF PHARMACY
KERALAM, INDIA03-2019
Skills
- Quality assurance
- ISO compliance
- Internal auditing
- Quality control checks
- Quality control checks and technical analysis
- Root cause analysis
- Quality issue resolution
- Quality risk management
- Quality assurance training
- Quality training programs
- Regulatory documentation
- Document management
- Compliance documentation
- Process improvement
- Data quality analysis
- Quality systems
Timeline
Quality Assurance Specialist
EVA-TEC DAC
05.2025 - Current
Production Support Specialist
EVA-TEC DAC
12.2024 - 05.2025
Quality Control Inspector(Packaging
ADVANT MEDICAL
07.2024 - 12.2024
Quality Assurance Inspector
BIOTEC HEALTH CARE PVT LIMITED
09.2023 - 07.2024
Manufacturing Specialist
BIOTEC HEALTH CARE PVT LIMITED
06.2023 - 08.2023
Quality Intern
SHINE STAR PHARMA HOSUR
11.2021 - 03.2022
MSC IN PHARMACEUTICAL BUSINESS AND TECHNOLOGY - Pharmaceutical Sciences
GRIFFITH COLLEGE DUBLIN
Bachelor of Science - Pharmacy
PUSHPAGIRI COLLEGE OF PHARMACY