QA Lead Specialist F/H

About ALK

A global leader in allergen immunotherapy (AIT), ALK is a Danish pharmaceutical company committed to the prevention, diagnosis, and treatment of severe respiratory allergies for over 100 years. Every day, more than 2 million patients benefit from our innovative therapeutic solutions. With a turnover of more than €500 million, ALK employs 2,800 people across 47 countries. The French affiliate (the Group’s second largest subsidiary) operates across three sites (Varennes-en-Argonne, Vandeuil, and La Défense) and plays a key role in the development and manufacturing of treatments. Allergy is a major public health issue whose consequences are often underestimated (worsening/development of asthma, sleep disorders, impact on quality of life, etc.). More than a quarter of the French population is affected, with a steadily increasing prevalence. Join a dynamic and committed team at ALK France and contribute to improving the quality of life of people living with allergies.

Mission

• Ensure that the validation strategy for computerized systems, manufacturing processes, cleaning processes, and analytical validation complies with GMP requirements and ALK Group policy
• Provide operational Quality Assurance support to cross-functional departments
• Drive continuous improvement and reporting of key performance indicators

Activities

• Approve/authorize validation documents for computerized systems, manufacturing processes, cleaning processes, and analytical validation (protocols, reports, plans, procedures, etc.)
• Approve deviations identified during validation studies
• Participate in and/or lead risk assessments
• Participate in local and global projects as QA validation representative
• Review and approve SAP master data change requests
• Review and approve change controls related to the scope of activity
• Participate in audits and inspections, as well as their preparation
• Contribute to quality initiatives and promote the quality culture within the company
• Propose improvements in line with regulatory requirements and group objectives

Profil

• Engineer or pharmacist (or equivalent experience) with at least two years of experience in a similar position
• English: Professional working proficiency
• Rigorous, autonomous, with strong teamwork and synthesis skills

Why you should join us

Working at ALK means joining an international group while benefiting from the advantages of a human-sized affiliate (visibility, concrete impact on activities, agile decision-making). At ALK, we value diversity, inclusion, and employee well-being. We are committed to minimizing our environmental footprint and supporting initiatives that improve the health and well-being of communities. Joining ALK means becoming part of a responsible and innovative company, where every day brings a new opportunity to make a difference.

For more information and to apply, visit our website: ALK.fr Join us and contribute to the fight against allergies!