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.
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).

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