Quality Control Specialist
Há 1 mês
Main Responsibilities
- Conduct physical and chemical tests under the stability studies scope.
- Operate and maintain stability studies infrastructure, including stability chambers and storage condition monitoring.
- Record all data, calculations, and results, and inform the responsible person of any out-of-specification or atypical result, collaborating in their investigation.
- Contribute to equipment and infrastructure maintenance and use according to established procedures and good practices to guarantee proper functioning and qualification state.
- Perform tasks under 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 policies, standards, and procedures in place.
- Collaborate in all department activities as needed.
Requirements
- 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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