Senior Quality Assurance Specialist

hace 1 semana


Madrid, Madrid, España Alk-Abelló Nordic A tiempo completo
About the Role

We are seeking a highly skilled Senior QA Specialist to join our team at Alk-Abelló Nordic. As a key member of our quality assurance department, you will play a critical role in ensuring that our manufacturing, packaging operations, and product quality meet the highest standards of cGMPs.

Responsibilities
  • Maintain internal Quality Systems: Change control, Deviations, CAPA, etc.
  • Review GMP technical and validation reports for manufacturing and packaging processes, computer/automated systems, cleaning validation/equipment cleaning procedures, laboratory and manufacturing equipment qualification, facilities and utilities with product contact, and analytical methods validation.
  • Provide quality support to technology transfer projects and provide on-site guidance in the preparation of procedures and working instructions.
  • Assist in providing resolution to GMP issues through identification of problem areas, refinement of systems, training, and coaching of relevant personnel.
  • Help maintain a permanent inspection readiness status and provide QA support for regulatory filings.
Qualifications

To be successful in this role, you will need:

  • A minimum of 5 years' experience in the pharmaceutical/biotech industry with a thorough knowledge of quality systems, GMP, and regulatory requirements.
  • A university degree in Chemistry, Pharmacy, Biology, or equivalent.
  • Fluent written and spoken English.
  • Thorough knowledge of sterile products regulation and oral solids forms technology transfer projects.
  • Expertise in interdisciplinary areas of pharmaceutical sciences, analytical chemistry, microbiology, cGMPs, regulatory issues, and data integrity regulation.
  • Strong interpersonal and leadership skills in dealing with various cultures on non-routine matters in stressful situations.
What We Offer

We offer a competitive salary of €80,000 - €110,000 per year, depending on your level of experience. You will also have access to ongoing training and development opportunities to help you grow your career within our company.



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