Qualified Person(QP)/Responsible Person - Plasma Manufacturing F/M

☞ Takeda

看过: 165

更新日: 26-11-2025

位置: Lessines Hainaut

类别: 质量保证/质量控制

行业: Pharmaceutical Manufacturing

水平: Mid-Senior level

工作类型: Full-time

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工作内容

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Job Description

About the role

Act as the delegate Qualified Person for our Factory of the future - Takeda Lessines.

Among your main activities, you will be providing support as Responsible Person in ensuring that the manufacturing, testing , labeling and packaging are in compliance with GMP and requirements of Marketing Authorization

How You Will Contribute
  • You will perform on time the batch release certification for components, intermediates and final packed products.
  • Ensuring batch certification and batch release are in compliance with EU guidelines (Eudralex volume 4, Annex 16) and local MOH requirements is one of your priority during your activity on site. You will also make sure that the medicines that are manufactured on our site and/or those imported by us are compliant with relevant regulations.
  • You will be handling legal reference and retention samples (sampling, storage, destruction).
  • Ensure the implementation of the principles and guidelines of good manufacturing practices are maintained.
  • Act as the site QP in case of absence of the Site QP or other delegate.
  • You will be support the implementation of projects for
  • Launches of new products and/or geographies.
  • QC changes methods/ tests in alignment with MOH requirements/ certification.
  • Editing declaration letters and QP statements to MOHs, OMCL and RA submission (new license registration, renewals, changes , clarification etc..).
  • The implementation of other projects aiming to improve our products and our patients’ life.
What You Bring To Takeda
  • You hold a University degree in Industrial Pharmaceutical Science.
  • You posses a QP Registration Number in Belgium (l’AFMPS-moniteur belge).
  • Knowledgeable in matters related to QP release (Eudralex, OMCL, other).
  • You are able to manage priorities in our dynamic and in the development environment.
  • You are someone with a critical thinking mindset, with an appreciation for teamwork and you enjoy being proactive and anticipate difficulties.
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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最后期限: 10-01-2026

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