Elisabetta Fustella is an experienced Pharmaceutical Quality Consultant and IRCA PQMS Associate Auditor with more than 20 years of experience in quality management within the pharmaceutical industry. She has a strong focus on GMP (Good Manufacturing Practice), quality operations and CMO (Contract Manufacturing Organisation) quality oversight.
Since December 2018, she is based in Belgium and she has been active as an independent consultant through EFGMPConsulting srl, where she supports international pharmaceutical and biotechnological organisations with GMP compliance, quality management, and supplier and CMO oversight. Her assignments have included roles such as External Quality (API) Senior Specialist, Deviation & CAPA Subject Matter Expert, GMP Quality Manager, Global Quality Lead Support and External Supplier Quality Assurance (DP) Manager. Her clients are in the top 10 pharmaceutical companies in the world.
Prior to her consultancy career, she held permanent positions within Quality Assurance and Quality Control, including Senior Quality Associate at Aspen Global, QA Officer at IBSA, GMP Compliance Officer at Developharma and Batch Record Review Responsible, Quality Control Analyst at Temmler Werke Holding. She began her career as a Quality Control Analyst Montefarmaco.
With her broad international experience, Elisabetta supports organisations in maintaining and improving quality and compliance within complex, regulated environments.
Expertise and Services
- Quality Assurance & Quality Operations
- Deviation & CAPA management
- Change Control Management
- Annual Product Quality Review
- Supplier & CMO Quality Oversight
- Quality Agreement
- GMP Compliance
- Auditing (IRCA certified)
- Aseptic Manufacturing
Positions
- Pharmaceutical Quality Consultant – EFGMPConsulting srl, Belgium (2018–present)
- Senior Quality Associate – Aspen Global, Mauritius (2015-2018)
- QA Officer – IBSA, Switzerland (2010-2015)
- GMP Compliance Officer – Developharma, Switzerland (2009)
- Batch Record Review Responsible, Quality Control Analyst – Temmler Werke Holding, Italy (2004-2009)
- Quality Control Analyst – Montefarmaco, Italy (2002-2004)
Education
- Master’s degree – Pharmaceutical Sciences (Chemistry)(University of Milan, 2002)
- Master’s degree – Regulatory Affairs and Market Access (University of Novara, 2013)
Skills
GMP • Quality Assurance • Quality Operations • Deviation & CAPA Management • Supplier & CMO Quality Oversight • Annual Product Quality Review • External Quality • Regulatory Affairs • CTD & Variations • Auditing (IRCA PQMS) • GMP Compliance • Pharmaceutical Manufacturing
LinkedIn
https://www.linkedin.com/in/0404e/
