Mihaela Noemi Papp
Dunboyne,Meath
Summary
Professional with extensive experience in GMP manufacturing operations and SOP compliance. Expertise in data integrity management (ALCOA+), batch record maintenance, and shift operations support. Skilled in troubleshooting and escalation processes, ensuring effective cleaning and line clearance. Strong collaborator with Operations and Quality Assurance teams, focused on driving efficiency and compliance in manufacturing environments.
Overview
5
5
years of professional experience
Work history
Operations specialist
Mallinckrodt Pharmaceuticals
Dublin, Leinster
2022.06 - Current
- Perform GMP manufacturing activities in line with SOPs, safety standards, and quality requirements
- Execute production tasks to support schedule delivery, ensuring accurate and timely completion of batch documentation
- Maintain strong compliance with data integrity and Good Documentation Practice (GDP) standards
- Applied Good Manufacturing Practices (GMP)s for smooth, safe production.
- Assist with cleaning activities, line clearance, and equipment preparation to maintain readiness and contamination control
- Contribute to shift handovers and communication across teams to ensure continuity and operational stability
- Collaborate with QA and support functions to ensure deviations and documentation queries are addressed efficiently
- Demonstrate flexibility to meet operational needs while maintaining a strong safety and compliance focus
Technical administrator
Bidvest Noonan Ireland
Dublin, Leinster
2021.02 - 2022.06
- Processed work orders in Blue Mountain (BMRAM) to ensure efficient operations.
Managed document control, including drafting, printing, and archiving documents.
Utilised Master Control for timely updates of critical documentation. - Manage emails, postal mail, and support event planning activities.
- Oversee office supplies, generate Purchase Orders (POs) as required, and assist company directors.
- Enhanced website and social media profiles for improved engagement.
Oversaw vendor and visitor management, issuing Work/Visitor Permits as required.
Education
Certificate of Higher Education - Food & Science Technology
TU Dublin
Tallaght, Leinster 2025.09 -
QQI Level 5 - Principles and Practice of Bioprocessing
AMTCE
Dundalk, Louth 2025.04 - 2025.06
QQI Level 6 - Pharmaceutical & Medical Devices
TU Dublin Tallaght
Tallaght, Leinster 2022.09 - 2023.05
Skills
- GMP manufacturing operations
- SOP compliance & GDP documentation
- Batch records / logbooks
- Data integrity (ALCOA)
- Shift operations support
- Cleaning & line clearance
- Troubleshooting & escalation
- Cross-functional collaboration (Ops/QA)
Timeline
Certificate of Higher Education - Food & Science Technology
TU Dublin
2025.09 -
QQI Level 5 - Principles and Practice of Bioprocessing
AMTCE
2025.04 - 2025.06
QQI Level 6 - Pharmaceutical & Medical Devices
TU Dublin Tallaght
2022.09 - 2023.05
Operations specialist
Mallinckrodt Pharmaceuticals
2022.06 - Current
Technical administrator
Bidvest Noonan Ireland
2021.02 - 2022.06