Senior Quality Assurance Expert

hace 2 días


Madrid, Madrid, España Alk Nordic AS A tiempo completo

Alk Nordic A/S is a global pharmaceutical company that helps people living with allergy. We are committed to improving quality, economy, and social responsibility. As a Senior QA Specialist, you will provide support for and be directly responsible for a range of Quality Assurance functions. This position will contribute to ensuring the performance of manufacturing, packaging operations, and product quality conforms to established cGMPs to ensure lasting customer satisfaction.

About the Role

This individual will demonstrate a high level of involvement in continuous improvement of the quality assurance philosophy and practice to ensure the right standards are implemented. Reports to: Quality Support Manager

Key Responsibilities
  • Perform Quality Assurance activities associated with maintaining internal Quality Systems: Change control, Deviations, CAPA, etc.
  • Review GMP technical and validation reports: Manufacturing and packaging processes. Computer/Automated systems involved in testing, manufacturing, or materials control.
  • Cleaning Validation/Equipment cleaning procedures. Laboratory and manufacturing equipment qualification. Facilities and Utilities with product contact. Analytical methods validation.
  • Provide quality support to technology transfer projects. Provide on-site guidance in the preparation of procedures and working instructions.

We are seeking an experienced professional with a minimum of 5 years' experience in the pharmaceutical/biotech industry and a thorough knowledge of quality systems, GMP, and regulatory requirements. The ideal candidate should have a university degree in Chemistry, Pharmacy, Biology, or equivalent.

Requirements
  • Minimum of 5 years' experience in the pharmaceutical/biotech industry.
  • University degree in Chemistry, Pharmacy, Biology, or equivalent.
  • Fluent in both written and spoken English.
  • Thorough knowledge in sterile products regulation.
  • Knowledge in oral solids forms and technology transfer projects is valuable.
  • Must have expertise in interdisciplinary areas of pharmaceutical sciences, analytical chemistry, microbiology, cGMPs, regulatory issues, data integrity regulation.
  • Strong interpersonal and leadership skills in dealing with a variety of cultures on non-routine matters in stressful situations, can deal with organizational complexity and ambiguity.

The estimated salary for this position is approximately $120,000 per year, depending on location and experience. We offer a competitive benefits package and opportunities for career growth and development.



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