QA Specialist

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 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 inspection readiness status.
• Provide GMP quality expertise, advice and/or assistance across the organization as required.

Required Qualifications and Skills:

• Minimum of 3 years’ experience in the pharmaceutical/biotech industry.
• Studies related to Chemistry, Pharmacy, Biology or equivalent (university studies are valued).
• Fluent in English, both written and spoken.
• Knowledge of regulations for sterile medicinal products and experience with technology transfer projects (mainly equipment qualification and process validation).
• Previous experience as a Qualified Person and proficiency with SAP would be desirable.
• Strong interpersonal and leadership skills in dealing with a variety of cultures on non-routine matters in challenging situations, can deal organisational complexity and ambiguity.
• Flexibility and a strong learning aptitude are required to support the different functions of the Quality Assurance department.

Why Join ALK?

• Professional Growth: Receive tailored training, participate in projects, and access unique learning opportunities within a leading international company.
• Collaborative Culture: Work alongside passionate professionals, share knowledge, and make a meaningful difference in a culture of respect, diversity, and integrity.
• Innovation and Excellence: Contribute with ideas and uphold the highest quality and regulatory standards.
• Competitive Benefits: Attractive salary, comprehensive benefits, and support for work-life balance.