Stability Studies Analyst

Detalhes MAIN ATTRIBUTIONS AND RESPONSIBILITIES• Perform physical and chemical tests under the scope of Stability Studies;• Operation and maintenance of the Stability Studies infrastructure (i.e.
stability chambers, storage condition monitoring);• Record all data, calculations and results and inform the responsible person of any out-of specification or atypical result and collaborate in their investigation;• Contribute to the proper maintenance of equipment and infrastructure and use it according to the established procedures and good practices in order to guarantee proper functioning and qualification state;• Perform tasks under the scope of qualification and computerized system validation plans,• Prepare protocols and test reports and participate in the preparation and review of technical documentation;• Collaborate in the investigation and CAPA definition of any Quality events;• Comply with GMP applicable to Quality Control activities;• Comply with safety standards applicable to physicochemical and microbiology laboratories;• Comply with the Policies, Standards and Procedures in place;• Collaborate in all department activities as needed.
Requisitos PREFERENTIAL REQUIREMENTS AND FACTORS• Degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences or Biochemistry;• Solid knowledge of instrumental analysis methods and wet chemistry;• Team player;• Strong computer and digital skills;• Solid knowledge of statistics applied to Quality Control (preferred).