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Job Description

About the role:

In yourrole as (Junior)Product QualitySpecialist, you will act as the Quality Representative for Regulatory Compliance for Biologics products as well as back-up for Plasma derivative products dispositioned by the Lessines facility.

How you will contribute:

• Ensure that the internal Quality systems are compliant with the quality specifications, license requirements and applicable regulations through the RA notification system, and maintenance of applicable local procedures.

• Coordinate Post Marketing Commitments for the Site.

• Act as a product quality expert for products packed and released by the site, providing expert support to the site internal functions.

• Respond to quality related requests from the global PQL (Product Quality Leads).

• Support the preparation of the necessary documentation for product license by providing the required information to the applicable RA (Regulatory Affairs) functions, in case of geographical expansion, tender or license renewal:

  • Prepare support documentation for changes and regulatory questions.

  • Respond timely to Regulatory Agencies questions or requests in relation of new licenses or application renewals.

• Assure timely issuance of the facility Product Quality Review (PQR) reports: coordinate data collection, assess conclusion of SME’s and evaluate the necessity of additional action, if applicable, as part of the final PQR summary report.
  Act as a key contact for internal and external partners to get report approval on-time.

• Review and ensure maintenance of Quality Agreements.

• Perform Inter-Facility Change Assessments (IFC) and Labeling change Assessments (ARC).

• Assure Activities related to Compliance Product Quality:

  • Coordinate Change Controls

  • Owner of specific Deviations

  • Veeva Expert

  • Bloom Training Expert

• Support on-site Regulatory Inspections.

What you bring to Takeda:

• You hold a University degree or equivalent: Engineering, Biochemistry, Chemistry or equivalent.

• Strong analytical and problem-solving skills.

  Prior experience in the pharmaceutical industry, accompanied by a thorough understanding of GMP.

• Demonstrated capacity for multitasking and efficient task management.

• Essential Qualities for Success:

  Organizational skills.
  Leadership capabilities.
  Innate curiosity.
  Effective communication.
  Flexibility in adapting to changes.
  Assertive decision-making.
  Proactive approach to challenges.

• Good knowledge of written and spoken French & English

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.

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