(Junior)Product Quality SpecialistLessines, Wallonia
At Takeda, Quality has always been a priority for us, throughout our long history. Today, what we do in Global Quality touches every part of our diverse organization. It’s reflected in our end-to-end Quality Management System that encompasses R&D, Manufacturing & Distribution, Commercial, Vaccines and our BioLife Plasma collection network. When you’re a part of our team, you’ll do meaningful work that makes an impact on the lives of patients. Learn more about us and explore the opportunities to build a remarkable career.
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
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:
Flexibility in adapting to changes.
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.
LocationsBEL - Lessines
Time TypeFull time
Working at Takeda
InclusionHere, you will feel welcomed, respected, and valued as a vital contributor to our global team.
CollaborationA strong, borderless team, we strive together towards our priorities and inspiring mission.
InnovationBold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
Top WorkplaceRecognized for our culture and way of working, we’re one of only 15 companies to receive Top Global Employer® status for 2023.
Work-LifeOur people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
EmpowermentThrough trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.
We're Steadfast In Our Commitment to Four Key Imperatives
Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.
Create an exceptional people experience.
Protect our planet.
Data & Digital
Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.
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