Are you looking for an exciting opportunity to develop your skills in an international pharmaceutical company, with the aspiration of becoming the general leader in allergy treatment? Join ALK We are leading global pharmaceutical company dedicated to improving lives for people living with allergies, and we are currently seeking for a Quality Assurance Specialist.

Job Purpose:

This position will contribute to ensure that performance of manufacturing, packaging operations and product quality are aligned with GMPs to ensure lasting customer satisfaction. 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.

Key Responsibilities:
- Perform Quality Assurance activities associated with maintaining internal Quality Systems: Technical complaints, Change controls, CAPAS, Deviations, etc.
- Management of APQR reports:
- Act as APQR lead coordinating inputs from the different Product Supply areas.
- Lead the APQR subsystem in the global forum.




- 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.
- Provides on-site guidance in the preparation of procedures and working instructions.
- Documentation and Training system:
- Reinforce good documentation practices in both paper and electronic media.
- Support the execution of GMP-training program.
- Support Quality Release activities:
- Master batch records review and related documentation.
- Site Master File update.
- Assists in providing resolution to GMP issues through identification of problem areas, refinement of systems, training and coaching of relevant personnel.
- Helps support a permanent

📌 QA Specialist (Madrid)
🏢 Alk-Abelló, A/S
📍 Madrid