Quality Assurance Specialist

hace 4 semanas

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.

**Key Responsibilities:**

  • **Quality Control and Assurance:** Collaborate with the Quality Assurance team to ensure that all processes within the Quality Control area are conducted in accordance with official requirements and regulations.
  • **Investigations and Troubleshooting:** Participate in investigations regarding deviations and out-of-specification analysis to identify root causes and implement corrective actions.
  • **Resource Management:** Collaborate with the Quality Control team to manage resources effectively, ensuring the smooth operation of the area and adapting to changing scenarios.
  • **Project Coordination:** Assist in the planning, coordination, and execution of various projects within the Quality Control 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:** Collaborate with the Quality Control team to develop departmental budgets, propose new investments, and create activity trend reports and continuous improvement actions.

**Requirements:**

  • **Education:** Bachelor's degree in Pharmacy or a related field.
  • **Experience:** 2-3 years of experience in the pharmaceutical industry, with a strong background in microbiology, chemistry, laboratory equipment, and analytical methods.
  • **Regulatory Knowledge:** In-depth knowledge of pharmaceutical industry regulations and pharmacopoeia.
  • **Language Skills:** High level of English proficiency.

**Desirable Qualifications:**

  • Postgraduate degree in Pharmaceutical Industry.
  • Experience in QA tasks.
  • Experience in deviation and out-of-specification investigations.
  • Experience in SAP environment, laboratory, and statistical data control software.

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