Daniela Núñez Leitón Email & Phone Number

Dubai, United Arab Emirates

Dubai, Emiratos Árabes Unidos

Lead and execute sterile test on new and overhauled filler machines on customer site, including verification of upstream set-up, CIP station, and laboratory work.Conduct unsterility investigations at the customer site, analyze complex data and recommend corrective actions.Lead the aseptic training program- develop and deliver aseptic microbiology training.Responsible of productions at the SIG Tech Center, managing the SPX upstream, including Mixer, Buffer Tank, UHT, Aseptic Tank, CIP system for both upstream and filler machine.Support on aseptic validations for pharmaceutical industry products using aseptic carton, including dynamic checkouts, challenge tests, media fills and product analysis. Expert in executing the most technically and scientifically challenging Microbiological tests, including identification.

Costa Rica

Implemented PepsiCo aseptic high acid manufacturing protocols for juices and sports drinks.Developed and implemented environmental monitoring program for aseptic production, including the preparation of technical documentation like SOPs, specifications, investigations and reports.Assisted management in establishing Quality Kpis, and project responsibilities.Participated in the internal and external audit program – including regulatory inspections, corporate / internal audits, Quality, HACCP, GMP and laboratory.Provided expertise in the development and launch of new aseptic beverages- from HACCP assessment to QC of new product trials.

Costa Rica

Conducted validation and commissioning of aseptic processes in accordance with “FDA analytical procedures and methods validations for drugs”.Implemented WHO Good Manufacturing Practices for pharmaceutical products.Drove Quality culture through coaching and training in microbiology.Continuously monitor the microbial quality of clean room environment and finished product testing.Conduct chemical analysis using quantitative methods such as UV spectrometry, liquid and gas chromatography, titration, etc.