QA Specialist

Employment type: FULLTIME. Are you looking for an exciting opportunity to develop your skills in an international pharmaceutical company, with the aspiration of becoming the global 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 qualification1 …