Senior Quality Assurance Specialist

hace 1 mes

Madrid, Madrid, España ALK A tiempo completo

As a Senior QA Specialist at ALK, you will play a key role in ensuring the quality of our pharmaceutical products. Your primary responsibility will be to provide support for and be directly responsible for a range of Quality Assurance functions.

This position will contribute to ensuring that performance of manufacturing, packaging operations and product quality conforms to established cGMPs to ensure lasting customer satisfaction.

You will demonstrate a high level of involvement in continuous improvement of the quality assurance philosophy and practice to ensure the right standards are implemented.

Key responsibilities include:

  • Performing Quality Assurance activities associated with maintaining internal Quality Systems: Change control, Deviations, CAPA, etc.
  • Reviewing GMP technical and validation reports.
  • Providing quality support to technology transfer projects.
  • Providing on-site guidance in the preparation of procedures and working instructions.
  • Assisting in providing resolution to GMP issues through identification of problem areas, refinement of systems, training and coaching of relevant personnel.

You will also support a permanent inspection readiness status, provide QA support for regulatory filings, prepare documentation for Material Review Board presentation and meetings, and provide GMP quality expertise, advice and/or assistance across the organization as required.

Requirements:

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

ALK is a global pharmaceutical company that helps people living with allergy. We are driven by a high level of professionalism, integrity, an open-minded approach and contributing to an inspiring and fun working environment together with colleagues.

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