Erika Palermo
Caserta,MB
Panoramica
3
3
years of professional experience
Esperienza lavorativa
Team Leader - Quality Audit
Patheon S.p.A. (part of Thermofisher)
Monza, MB
07.2022 - ad oggi
- Coordinate, mentor and develop audit team members (audit specialists).
- Collaborate cross-functionally with QA, Production and senior management.
- Lead and oversee the internal audit program.
- Define and execute risk-based internal audits across production, QC, QA, warehouse and critical services.
- Act as audit host and main point of contact for customer audits and regulatory authorities inspections.
- Define and implement audit readiness strategies to ensure continuous inspection readiness.
- Coordinate cross-functional teams during pre-audit preparation, on-site execution and post audit follow-up
- Review, approve and submit formal responses to audit observation.
- Oversee CAPA governance, ensuring effectiveness and regulatory compliance.
- Serve as Subject Matter Expert during inspections by Regulatory Authorities and customer audits.
- Trend and analyze audit findings and quality metrics.
- Support Quality Risk Management activities.
- Execute dedicated training sessions to site Subject Matter Experts on how to interact with inspectors.
- Complete Gap Assessments related to inspections findings.
- Foster a positive and supporting work environment to enhance team engagement and development.
- Active involvement in projects aimed at optimizing inspection-related processes.
Audit Specialist
Patheon S.p.a (part of ThermoFisher)
Monza, MB
07.2021 - 07.2022
- Prepare and coordinate customer and regulatory inspections.
- Coordinate CAPA development, responses and follow-up.
- Support inspections by AIFA, EMA, FDA and RoW health authorities as part of backroom team.
- Maintain accurate, inspection-ready audit documentation and records.
- Monitor any corrective and preventive action assuring on time closure.
- Ensure compliance with EU GMP, FDA 21 CFR, ICH guidelines and data integrity principles (ALCOA+).
- Organize and / or manage the backroom during the inspection.
- Management and issuance of Quality Technical Agreement between Patheon and Customers
Compliance Officer
AbbVie S.r.L
01.2020 - 06.2021
- The main activities are about the managing of external inspections in particular:
- Collaborate with the entity that plans the audit, with the support of the functions concerned, to provide the required documentation and define the audit timescales;
- Coordinate and verify the inspection readiness to identify critical issues of the quality system, processes, products, areas and equipment subjects of the inspection, preparing, if necessary, action plans to mitigate the risk.
- Plan the audit agenda
- Organize and / or manage the backroom during the inspection
- Collaborate, after the inspection, in the drafting, finalization and transmission of the action plans (CAPA) and their updates to the entity that performed the audit, keeping the evidence files updated
- Manage paper-based inspection
QA Compliance intern
Abbvie s.r.l.
07.2019 - 12.2019
- The training focused on:
- The methods used to manage the assessments of the impact of new/revised global procedures on local documentation and/or activities, processing the data provided by the different departments regarding the analysis of the processes towards the defined procedures;
- The methods to manage the assessments of the impact of new regulations/requirements on local documentation and processes;
- Procedures for data processing and preparation of the material for the site Management Reviews with the activities described above;
- Participation as a member of the backroom in corporate and AIFA inspections.
Istruzione
License to practice the profession of Pharmacist -
University of Naples, Federico II
03.2019
License to practice the profession of Pharmacist - undefined
University of Naples, Federico II
11.2019
Competenze
- People Management
- Leadership
- Reliability and accountability
- Strong communication and interpersonal skills
- Results-oriented
- Strong team player
- KPI analysis and trend evaluation skills
- GMP Compliance
- Proactive mindset
- CAPA Management
- Quality Risk Management
- Problem solving
- Advanced general PC Computer skills
- Microsoft Office application
- SAP
- TrackWise
- PMX
LANGUAGES
Italian: native
Madrelingua
C2
English: oral and written fluency
Esperto
C2
Spanish: oral and written proficiency
Intermedio avanzato
B2
Risultati conseguiti
- “Erasmus +” Program (September 2015 - September 2016) | University of Granada, Faculty of Pharmacy, Spain.
- Pharmacy Training (January 2017- January 2018): via dei Caduti sul Lavoro, 37, 81100 Caserta. Dott.ssa Rosa Ferreri.
- Development of polymeric nanoparticles for anticancer therapies (September 2017- March 2019) | University of Naples, Federico II.
REFERENCES AVAILABLE UPON REQUEST
(in whatever activity displayed on my C.V)
Cronologia
Team Leader - Quality Audit
Patheon S.p.A. (part of Thermofisher)
07.2022 - ad oggi
Audit Specialist
Patheon S.p.a (part of ThermoFisher)
07.2021 - 07.2022
Compliance Officer
AbbVie S.r.L
01.2020 - 06.2021
QA Compliance intern
Abbvie s.r.l.
07.2019 - 12.2019
License to practice the profession of Pharmacist - undefined
University of Naples, Federico II
License to practice the profession of Pharmacist -
University of Naples, Federico II