QA Validation Engineer
Life Sciences
QA
- Emplacement
- Geel, Antwerp
- Type de travail
- Consultancy
- Modèle de travail
- Fulltime, Hybrid
Responsabilités
Join a dynamic project team dedicated to upholding the highest standards of quality and compliance within the pharmaceutical industry. We seek a motivated professional eager to contribute to our mission of ensuring rigorous quality in every aspect of the commissioning, qualification, and validation processes.
As the ideal candidate, you are a skilled QA Engineer with significant experience in mechanical quality assurance and validation, passionate about ensuring compliance with stringent industry standards. If you are detail-oriented and dedicated to quality, this role is perfect for you.
- You participate in validation risk assessments and provide quality input throughout project phases (Design, Commissioning, IOQ, PQ).
- You review and approve commissioning and qualification protocols, test scripts, and reports for manufacturing equipment and computerized systems.
- You verify that qualification activities are performed according to established procedures and regulatory requirements.
- You provide quality oversight during the execution of qualification activities.
- You review and approve change controls and other quality documentation related to CQV activities.
- You work closely with various teams including Commissioning, Qualification/Validation, Engineering, Manufacturing, and Technical Services.
- You provide quality guidance to stakeholders on validation requirements.
Exigences
- You hold at least a Bachelor's degree in Pharmaceutical Sciences, Engineering, Chemistry, Biology, or a related scientific/technical field.
- You have a minimum of 3 years of experience in the pharmaceutical/biotech industry, focusing on CQV activities.
- Additional qualifications in Quality Assurance or Validation are a plus.
- You have demonstrated knowledge of qualification and validation principles.
- You possess experience with GMP manufacturing environments.
- You have a thorough understanding of EU GMP, FDA regulations, and ICH guidelines.
- You have excellent communication skills for effective collaboration with project teams.
- You are detail-oriented with a focus on assuring high-quality projects.
- You exhibit strong problem-solving abilities and the capacity to make decisions in dynamic project environments.
- You have multilingual proficiency for effective communication in diverse engineering contexts (English and Dutch).
- You have strong interpersonal skills and the ability to work in cross-functional teams.
- You are capable of managing multiple priorities and meeting deadlines.
Offre
- Bénéficiez d'un package salarial compétitif avec des avantages supplémentaires qui récompensent votre talent.
- Faites évoluer votre carrière avec un parcours clair, du coaching et du mentorat pour vous accompagner.
- Épanouissez-vous dans un environnement dynamique et bienveillant où vous pouvez réellement faire la différence.
- Travaillez où et quand vous êtes le plus performant pour un équilibre travail-vie optimal.
- Optez pour une solution de transport flexible, d'une voiture de société à un abonnement aux transports en commun.
- Développez votre réseau et vivez des moments inoubliables lors d'événements exclusifs et afterworks.
- Développez vos compétences grâce à des formations externes et notre Pauwels Academy interne.
- Travaillez sur des projets stimulants avec des leaders dans les domaines Life Sciences, Engineering & Digital.
- Saisissez des opportunités à tous les niveaux, d'un excellent départ à une progression rapide et une collaboration experte.
# 91871
)