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Clinical and Medical Platforms Architecture

Employer
Takeda
Location
Cambridge, Massachusetts
Start date
Sep 18, 2024
View more categoriesView less categories
Discipline
Clinical, Clinical Research
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Genetown, Best Places to Work

Job Details

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’sPrivacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

Job title: Quality Validation Analyst

Location: Rieti

Descrizione del lavoro:

Stiamo cercando un/una Quality Validation Analyst appassionato/a e con esperienza per unirsi al nostro team diversificato e dinamico. La risorsa avrà il compito di garantire che i processi di produzione e i sistemi rispettino i più alti standard di qualità e le normative vigenti, contribuendo al continuo miglioramento dei nostri processi in un ambiente inclusivo e collaborativo.

Responsabilità principali:

  • Revisione e approvazione di protocolli di convalida, report, rapporti di deviazione, specifiche, valutazioni del rischio, piani di convalida e documentazione collegata.

  • Esecuzione della funzione di Quality per quanto riguarda gli assessment di calibrazione, in accordo con le procedure aziendali.

  • Verifica e mantenimento dello stato di convalida delle attrezzature, dei sistemi, dei processi di cleaning e di produzione.

  • Collaborazione attiva in progetti come rappresentante del reparto Quality Validation, promuovendo la diversità di pensiero e l’innovazione.

  • Monitoraggio delle attività di validazione e analisi dei dati relativi agli indicatori di performance.

  • Gestione e tracciamento dei documenti e delle attività di riqualifica/revisione periodica per i sistemi di manufacturing.

Requisiti:

  • Laurea in discipline scientifiche (Chimica, Biotecnologie, Farmacia o campi affini).

  • Esperienza nel settore farmaceutico, con un focus sulla convalida di processi e sistemi.

  • Conoscenza approfondita delle normative GMP.

  • Eccellenti capacità organizzative, analitiche e di problem-solving, con una mentalità orientata alla qualità e all’innovazione.

  • Buona padronanza della lingua inglese e degli strumenti informatici.

  • Siamo aperti a candidati con esperienze e background diversi che possano arricchire la nostra cultura aziendale.

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 status, or any other characteristic protected by law.

Locations

ITA - Rieti

Worker Type

Employee

Worker Sub-Type

Fixed Term (Fixed Term)

Time Type

Full time

Company

Takeda is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries and regions.

For more information, visit https://www.takeda.com.

Stock Symbol: TAK

Company info
Website
Location
650 East Kendall Street
Cambridge
MA
02421
US

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