Qualified Person

☞ Takeda

View: 160

Update day: 26-11-2025

Location: Lessines Hainaut

Category: Quality Assurance / Quality Control

Industry: Pharmaceutical Manufacturing

Job type: Full-time

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Job content

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Job Description

About the role

Act as the delegate qualified person for Baxalta Belgium Manufacturing S.A. in accordance with applicable regulations.

How You Will Contribute

Support the site QP in ensuring that the manufacturing, testing , labeling and packaging are in compliance with GMP and requirements of Marketing Authorization
  • Perform on time the batch release certification for components (SWFI and PH20…)
  • Perform on time the batch release certification for intermediates
  • Perform on time the batch release certification (final packed products)
  • Ensure batch certification and batch release is in compliance with EU guidelines (Eudralex volume 4, Annex 16) and local MOH requirements
  • Handle legal reference and retention samples (sampling, storage, destruction)
  • Ensure the implementation of the principles and guidelines of good manufacturing practices are maintained.
  • Compliance monitoring of medicines manufactured and / or imported by Baxalta Manufacturing Belgium S.A.
  • Act as the site QP in case of absence of the Site QP or other delegate.
  • Act as owner of all batch release protocols/certificates
  • Support the implementation of projects for
  • Launches of new products and/or geographies
  • QC changes methods/ tests in alignment with MOH requirements/ certification
  • Redact declaration letters and QP statements to MOHs, OMCL and RA submission (new license registration, renewals, changes , clarification etc..)
  • Other improvement projects
What You Bring To Takeda
  • University degree in Industrial Pharmaceutical Science
  • QP QP Registration Number (l’AFMPS-moniteur belge)
  • Knowledge in guidance needed for QP release (Eudralex, OMCL…)
  • Ability to manage priorities
  • Stress-resistant
  • Conscientious
  • Team-spirit
  • Proactivity
  • Critical thinking
More About Us

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Empowering our people to shine

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information, or characteristics, marital or other status. At Takeda, we embrace diversity as a whole.

#GMSGQ

Locations

BEL - Lessines

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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Deadline: 10-01-2026

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