QA Lead Specialist / Chargé(e) AQ Qualification & Validation (F/H)

ALK-Abello; Isterød; On-site; DKK 410,447 - 559,701; Full time

Job summary

ALK-Abello is looking for a Quality Assurance professional to ensure compliance with GMP requirements and provide operational support. The ideal candidate is an engineer or pharmacist with at least two years of experience in a similar role. You will approve validation documents, contribute to risk assessments, and promote a quality culture within the company. Join a dynamic team committed to improving quality of life for allergy sufferers.

Qualifications

• At least two years of experience in a similar position.
• Rigorous and autonomous in work.

Responsibilities

• Ensure compliance with GMP requirements and ALK Group policy.
• Drive continuous improvement and report key performance indicators.
• Approve validation documents for various processes.

Skills

Teamwork skills

Synthesis skills

Professional working proficiency in English

Education

Engineer or pharmacist (or equivalent experience)

Job description

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.

Application

For more information and to apply, visit our website: ALK.fr.

Join us and contribute to the fight against allergies!