Alice Motta Email & Phone Number

- Mother of three;- Review/elaboration/impact assessment of specifications and analytical methods of raw materials, intermediates and expected products, according to monographs and general chapters in pharmacopoeias, internally analytical methodologies and regulatory standards;- Analysis of finishing products and raw materials, working with HPLC, UPLC, CG, UV-Vis, IR, Titration, Dissolution techniques;- Review/conference of raw analysis data;- Preparation/review of protocols and validation/transfer reports of analytical methods;- Preparation/review of protocols and reports on stability indicative method (forced degradation) and discriminative method (dissolution profile);- Participation in investigations of out-of-trend/specification results;- Preparation/review of change control and post-registration documentation (Technical justification, PATE, etc.), SOPs and work instructions;- Conducting training;- Auditoriums (external and internal);- Knowledge of legislation in the area of ​​medicines (RDC 301/2019, RDC 166/2017, RDC 73/2016, RDC 31/2010, RDC 318/2019, RDC 53/2015, ICH Q3C and ICH 3QD).

Listed skills include Hplc, Gmp, Quality Control, Ir, and 8 others.