Ana Karina de Sousa Serrao

- Lead and plan all QC activities; - Review, approve and report of generated data for QC release; - Preparation of SOP's, technical protocols/reports, deviations and investigation reports and change control; - Coordinate equipment maintenance/calibration or repairs with contract suppliers; - Communicate effectively with other relevant groups; - Participate in internal and regulatory audits as required; - Inventory and order of all materials for lab consumption; - Work under FDA approved environment.

- HPLC, pH Meter, Karl-Fischer, Coulometric KF, Water for Headspace, Spectroscopic Methods (UV, IR); - HPLC Instrument calibration and maintenance (Waters® e Agilent®); - HPLC training administration; - Advanced use of Chromeleon 7.2 and Empower 3; - Executing and evaluating new method transfer projects as well as process validation of analysis; - Preparation of protocols and reports; - Documentation in accordance with SOPs; - TOC Determination; - Experience in GMP/FDA regulated industry.

- Finished product Analysis using diverse techniques such as HPLC (Empower and Chromeleon Software), TLC, IR, UV, classic chemical tests (Karl Fischer water Content Determination, sub-visible particles quantification using Royco Equipment, osmolarity, - work developed under GMP Environment, - manage and sending of samples to other subsidiary, - retrieve and storage of samples in stabilty Chambers.

- Samples collection, ad storage in stability chambers, - Chemical analysis in products in liquid state, cephalosporins and lyophilizates, - Usage of Spectroscopic methods (UV, IR), water content determination by titration (Karl Fischer), quantitative methods for determination of sub-visible particles, potentiometry and chemical identification of compounds