Paloma Passamani, MSc.
QA/RA Consultant
Personal Profile
Execution and implementation of Regulatory and Quality strategies in the area of blood and biological products, borderline device/drug products, animal and human tissue derived products, combination products and advanced therapy medicinal products. Experienced in CMC, IMPD and scientific advice writing, for various applications or different countries and project management. Participated in successful application of BLA (FDA) and MAA (EMA) approval for a biological blood product in combination with a medical device. Any regulatory interaction and/or approval related to e.g. scientific advices, clinical and market approvals drives me to stay focused, milestone driven and guard timelines without compromising high quality working standard.
Specializations
- CMC
- MDR
- ISO 13485
- Project Management
- Blood/Biological products
- Combination products
- Cell therapy
- Human tissues
Courses and Certifications
- Importance & Requirements of Clinical Evaluation
- Internal Auditor: ISO 13485 (BSI)
- Introduction and cGMP guidelines, Microbiology, Cleaning, Disinfection & Sterilization, Aseptic production, EM & Media fills
- Pharmaceutical areas and HVAC
- Validation & Qualification, Guidelines, Registration & Inspection and General GMP
Paloma Passamani
Professional Experience
QA / RA Consultant
Signifix | 2017 –present
Manager Chemistry, Manufacturing, and Control (CMC)
Mallinckrodt Pharmaceuticals
(acquired from The Medicines Company in February 2016, and ProFibrix B.V. on its turn in August 2013),
Dublin, Ireland | 2012 – 2017
Senior Technology Transfer Officer
Octoplus | 2010 –2011
Interim Supervisor Clinical Production
Octoplus | 2010
Project Coordinator and Process Engineer
Octoplus | 2007 –2009
Biochemical Engineer
Xendo | 2005 – 2007
Paloma Passamani
Academic Education
Master of science in biotechnology at University of Wageningen
Specialization: bioprocess technology courses such as bioprocess technology, process design, system and control theory
Biotechnologie at Noordelijke Hogeschool
Leeuwarden in cooperating with the Van Hall Institute Specialization: bioprocess technology
