Pharmaceutical Quality Assurance Specialist

hace 2 días


Madrid, Madrid, España Alk Nordic AS A tiempo completo

Join a global pharmaceutical company at the forefront of allergy treatment as a Senior QA Specialist. We help people living with allergy by providing innovative solutions, and we're committed to making allergy surprisingly simple to manage.

About the Role

This is an excellent opportunity for you to provide support for and be directly responsible for a range of Quality Assurance functions. As a Senior QA Specialist, you will contribute to ensuring that manufacturing, packaging operations, and product quality conform to established cGMPs. 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.

Responsibilities:
  • Maintain 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.
  • On-site guidance in the preparation of procedures and working instructions.
  • Identification of problem areas, refinement of systems, training, and coaching of relevant personnel.
  • Aiding a permanent inspection readiness status.
  • QA support for regulatory filings.
  • Preparation of documentation for Material Review Board presentation and meetings.
Requirements:
  • Minimum 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.
  • Fluent in both written and spoken English.
  • Thorough knowledge in sterile products regulation.
  • Knowledge in oral solids forms and technology transfer projects valuable.
  • 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.
Salary and Benefits

The estimated salary for this role is €80,000 - €100,000 per annum, depending on your qualifications and experience. In addition to your base salary, you'll enjoy a comprehensive benefits package including pension scheme, life insurance, health insurance, and paid holidays.

We strive to create a positive work environment that promotes growth and collaboration among team members. If you're passionate about making a difference in the lives of people living with allergy, please consider joining our dynamic team.



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