About the role: This position is part of the Quality Assurance Team of the Madrid Site, being responsible for reviewing and dispositioning the Batch Documentation, reporting directly to QA/QP Head. Please note this is a hybrid work model mostly with the afternoon shift.
How you will contribute:
Batch Record Review and Batch disposition of clinical trial and commercial medicinal products.
Management of Deviations, OOS and related CAPAs. Collaborate in all quality events, Change Control implementation, Claims and Recalls.
Review and approve SOP and related GMP documents.
Contribute to the compilation of data for the Operational Review Board meetings and Annual Product Review.
QA Liaison to other events.
Shop floor QA activities to support the process.
Act as a deputy Qualified Person when needed.
Artworks Approval.
Whatever other task required always in compliance with the CBA (art.22 & art.26).
What you bring to Takeda: Education and experience
Degree in Pharmacy. Postgraduate studies are an asset.
At least 2 years prior experience in a GMP certificate pharmaceutical or biotech company, in the qualified deputy position or experience in the analysis of Medicinal Product and Active Ingredients.
Ability to operate independently, being flexible and set own agenda but also team work oriented.
Skills and Competencies
Functional: Knowledge of aseptic processing in a clean room environment.
Technical: General expertise working with computers at user level, including MS Word, MS Power Point, and MS Excel. Fluent in English, speaking and writing. Good communication, presentation, and reporting skills.
Behavioural/Interpersonal: Pro-active and quality-driven oriented. Team-oriented with good interpersonal skills. Flexible working attitude open to changes.
Travel requirements: According to the position, occasional travels.
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 of 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 status, or any other characteristic protected by law.
Locations: Madrid, Spain
Worker Type: Employee
Worker Sub-Type: Regular
Time Type: Full time
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