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Senior Quality Assurance Specialist

hace 1 mes

Madrid, Madrid, España Alk-Abelló A tiempo completo

Job Summary

We are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Alk-Abelló. As a key member of our Quality Assurance department, you will be responsible for ensuring the quality and integrity of our products.

Key Responsibilities

  • Perform quality assurance activities associated with maintaining internal quality systems, including change control, deviations, and CAPA.
  • Review GMP technical and validation reports.
  • Provide quality support to technology transfer projects.
  • Assist in providing resolution to GMP issues through identification of problem areas, refinement of systems, training, and coaching of relevant personnel.
  • Support QA management as required.

Requirements

  • Minimum of 5 years' experience in the pharmaceutical/biotech industry with a thorough knowledge of quality systems, GMP, and regulatory requirements.
  • University degree in Chemistry, Pharmacy, Biology, or equivalent.
  • Essential skill: Fluent in communications (both written and spoken) in English.
  • Thorough knowledge in sterile products regulation.
  • Oral solids forms and technology transfer projects knowledge is valuable.

About Us

At Alk-Abelló, we are committed to making allergy surprisingly simple to manage. With 100 years of experience and almost 3,000 employees around the world, we have a deep understanding of the complexities of allergy and a passion for delivering innovative solutions.