Quality Assurance Specialist

hace 1 mes

Madrid Centro, Madrid, España Qualicaps LLC. A tiempo completo
Job Summary

We are seeking a highly skilled Quality Control Technician to join our team at Qualicaps LLC. This individual will play a crucial role in ensuring the quality and compliance of our products, collaborating with the Quality Assurance department to guarantee adherence to regulations and internal procedures.

Key Responsibilities
  • Process Control and Compliance: Verify that all processes within the Quality Control area are conducted in accordance with official requirements and regulations, ensuring that product specifications meet client requirements and certifying analysis results for batch review.
  • Investigation and Collaboration: Participate in investigations regarding deviations and out-of-specification analysis, working closely with the Quality Assurance team to identify and resolve issues.
  • Resource Management: Collaborate in the management of resources within the QC area, adapting to various scenarios to ensure the performance of the area.
  • Project Planning and Execution: Assist in the planning, coordination, and execution of projects within the QC area, including equipment purchases, validations, environmental control, equipment maintenance, and cleaning plans.
  • Procedure Review and Update: Review and update procedures according to regulations, ensuring compliance with FDA, Pharmacopoeia, ISO, H&S, and other relevant standards.
  • Departmental Support: Contribute to departmental budget proposals, new investments, and area activity trend reports, as well as propose continuous improvement actions.
Requirements

We are looking for a candidate with a positive attitude, willing to join a dynamic position within our Quality Control Department. The ideal candidate should possess the following qualifications:

  • Education: Degree in Pharmacy.
  • Experience: 2-3 years of experience within the pharmaceutical industry.
  • Knowledge and Skills: Familiarity with microbiology, chemistry, laboratory equipment, and analytical methods, as well as knowledge of pharmaceutical industry regulations and pharmacopoeia.
  • Language Proficiency: High level of English proficiency.
Desirable Qualifications
  • Postgraduate Education: Pharmaceutical Industry Postgraduate degree.
  • QA Experience: Experience in QA tasks.
  • Investigation Experience: Experience in deviation and out-of-specification investigations.
  • Technical Skills: Experience in SAP environment, laboratory, and statistical data control software.

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