Daniele Callea
Quality Assurance Manager
Lugano
Summary
Quality Assurance Manager with experience in the pharmaceutical sector in GMP compliance, computerized system validation (CSV), and audit management. Graduated with honors in Medicinal Chemistry and Pharmaceutical Technology, with research experience in European projects. Distinguished by determination and result-oriented approach, ensuring compliance, efficiency, and continuous improvement in business processes.
Overview
4
4
years of professional experience
3
3
Languages
Work History
Quality Assurance Manager
Osmopharm S.A.
09.2024 - Current
Initially hired as Deputy Technical Director (QA & Compliance), later promoted to QA Manager.
- Management of Quality Assurance activities, ensuring GMP compliance.
- Conducting client audits and regulatory inspections.
- Handling Change Control, CAPA, and complaints.
- Drafting and updating QA documentation, including SOPs, VMP, SMF, and Quality Manual.
- Reviewing Batch Records, COA, and COC for GMP-compliant batch release.
- Validation of Computerized Systems (CSV) and data integrity management.
- GMP training for personnel to strengthen quality culture.
- Implementing safety strategies and continuous process improvement.
Researcher in Nanomedicine (Visiting Researcher)
Institute of Materials Science (ICMAB-CSIC)
02.2024 - 05.2025
European Project Nano4Rare - Erasmus Traineeship.
- Development of liposomal nanoformulations for Fabry Disease.
- Characterization of formulations using DLS and TFF diafiltration.
Master's Thesis in Medicinal Chemistry
University of Helsinki
03.2023 - 09.2023
Pharmaceutical Chemistry Laboratory - Erasmus Scholarship.
- Synthesis of 5-aminothiazole compounds for neurodegenerative disease treatment.
- Skills: NMR, Mass Spectrometry, Flash Chromatography, and TLC.
- Laboratory safety practices and reagent management.
Final Grade: 15/15
Pharmacist
Nava Pharmacy
07.2021 - 07.2022
Curricular Internship (900 hours).
- Patient care and empathy.
- Preparation of galenic pharmaceutical formulations.
- Ensuring safety and regulatory compliance.
Education
Master of Science - Medicinal Chemistry And Pharmaceutical Technology
University of Pavia
Pavia, Italy 04.2001 -
High School Diploma, Applied Science -
L. Cobianchi
Verbania, Italy 04.2001 -
Skills
- GMP, GDP, Regulatory Compliance
- Audit & Regulatory Inspections Management
- Change Control, CAPA, QA Documentation
- Computerized System Validation (CSV)
- Personnel Training & Quality Culture
- Laboratory Techniques: NMR, Mass Spectrometry, HPLC, TLC
- Problem Solving & Leadership
Timeline
Quality Assurance Manager
Osmopharm S.A.
09.2024 - Current
Researcher in Nanomedicine (Visiting Researcher)
Institute of Materials Science (ICMAB-CSIC)
02.2024 - 05.2025
Master's Thesis in Medicinal Chemistry
University of Helsinki
03.2023 - 09.2023
Pharmacist
Nava Pharmacy
07.2021 - 07.2022
Master of Science - Medicinal Chemistry And Pharmaceutical Technology
University of Pavia
04.2001 -
High School Diploma, Applied Science -
L. Cobianchi
04.2001 -
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