Eva Newti

Detail-oriented Quality Control Analyst with three years of experience in GMP-regulated pharmaceutical industry. Experienced in ensuring regulatory compliance by using quality management systems, updating SOPs, conducting root cause analysis and conducting laboratory investigations and CAPAs. Strong knowledge of EU GMP requirements and audit readiness to ensure operational excellence. Seeking to transition into Regulatory Affairs to collaborate with teams to ensure regulatory alignment.

Quality Control Analyst - Viatris - Dublin

(2023-09)

• Conduct Analytical Quality Control and stability testing on respiratory medical devices, in accordance with GMP and GLP guidelines.
• Coordinate sample lifecycle activities such as sample receipt in accordance with GMP requirements.
• Partner with R&D and cross-functional teams to support technical transfers, analytical troubleshooting, and continuous improvement initiatives.
• Conduct root cause investigations for analytical deviations implementing CAPAs to support right-first-time performance and product quality.
• Participate in non-routine laboratory investigations, technical projects, and process improvement initiatives.
• Review analytical data to ensure data integrity, accuracy, and compliance with GMP requirements.
• Support internal and external audit readiness through documentation review, SOP compliance, inspection preparation, and EHS initiatives. Serving as SME for two analytical tests.
• Maintain and periodically review SOPs, analytical methods, and controlled documentation to ensure continued regulatory compliance and alignment with current practices.
• Perform calibration, preventive maintenance, troubleshooting, and performance verification of laboratory instrumentation, including HPLC and UPLC systems.
• Train new laboratory personnel on GMP documentation, laboratory procedures, and operational standards.
• Contribute to Operational Excellence initiatives, including Kaizen and 6S, to improve laboratory efficiency, compliance, and workflow effectiveness.
• Assist with laboratory risk assessments, hazard mitigation activities, and inventory management to support uninterrupted laboratory operations.
• Represent Quality Control in cross-functional meetings, technical discussions, and R&D collaborations to support successful project execution.
• Act as the Laboratory Safety Representative by conducting laboratory risk assessments, promoting Incident Prevention Opportunities (IPOs), leading safety initiatives projects, and representing the QC laboratory during safety audits as the subject matter expert.

Data Analyst Intern - AIB - Dublin

(2021-05 - 2021-08)

• Performed data quality assurance monitoring of systems by performing user access management and review using JIRA.
• Communicated with key data and analytics stakeholders and produced structured reports on completion to identify operational issues.
• Used data management and analytical tools and practices, including Excel and JIRA Software, to create valuable insights informing business decisions to maintain data integrity.
• Proven ability to work both independently and collaboratively, ensuring all key deliverables are met by leveraging prioritisation and time management abilities.
• Improved operational efficiency by researching and implementing a faster Excel reporting solution that replaced a manual time-consuming process. Led to permanent adoption by the team, received recognition for initiative and problem-solving.
• Recognised by management for initiative, innovation, and problem-solving, resulting in an offer to extend the internship.

Freelance Qualified Nail Technician - Self-employed - Dublin

(2020-05)

Hospitality Assistant - Aviva Stadium - Dublin

(2020-02 - 2021-06)

B.Sc (Hons) - Pharmaceutical and Chemical Sciences - Dublin City University (2019-09 - 2023-05)

H.Dip (Level 8) - Quality System Validation with Data Analytics - Munster Technological University (2026-09)