Qualified Person / Investigational Medicinal Products (f/m/x)


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Job Description

About the role:

How you will contribute:

  • Act as Qualified Person (QP) in accordance with applicable regulations for Investigational Medicinal Products (IMPs) in the Pharmaceutical Science Quality Europe group of the global Pharmaceutical Science & Device Quality organization of Takeda

  • Perform QP certification activities with responsibility for Takeda IMPs in the fields of biologics, small molecules and plasma derived products in accordance with their Clinical Trial Authorization (CTA), their IMP Dossier and their Manufacturing Authorizations and the principles and guidelines of cGMP as laid down in Directive 2017/1572 and Delegated Regulation 2017/1569 and in accordance with principles and the detailed guidelines of Good Manufacturing Practice for Medicinal Products

  • Provide QA/QP support for work performed at, contract manufacturers and analytical laboratories, and coordinate priorities and workload with key stakeholders to ensure the quality of investigational medicinal product and compliance with cGMP

  • Provide GMP QA expertise and principles during the development, manufacturing, testing, packaging and release of clinical trial material

  • Responsibility for the successful, timely completion of goals and objectives, which will strengthen the Takeda R&D Quality organization

What you bring to Takeda:

  • Master’s degree in chemistry, biology, pharmacy or a related discipline

  • Eligibility to act as Qualified Person in line with local and EU directives

  • At least 3 years experience working in Quality Assurance role or in a QA environment in the pharmaceutical industry (in a clinical manufacturing/packaging environment preferred)

  • Thorough understanding of quality systems and cGMPs

  • Operational experience and technical understanding of standard manufacturing and packaging processes for a variety of dosage forms

  • Must be able to critically evaluate completed manufacturing documentation and assess to determine compliance with SOPs, IMPDs and clinical trial authorizations

  • Interpersonal skills and professional skills to interact with external contract manufacturers/supplier/test labs, representing Takeda

  • Must be able to prioritize and multitask in a stressful environment

  • Must be able to read, understand, speak and write technically and legibly in English as well as in German

    What Takeda can offer you:

    A competitive remuneration package with a minimum salary of € 4.751,92 gross per month (full-time, collective wage agreement for the chemical industry) - the actual salary depends on your professional experience and qualifications!

    • Family-friendly company environment; Support with parental leave, dad month, Bilingual company kindergarten
    • Work @ home depending on the position / department
    • Comprehensive training programs
    • In-house job rotation program
    • In-house Canteen with discounts or meal vouchers
    • Works council (events, festivals, shopping vouchers, etc.)
    • Employee Referral Program
    • Employee Recognition Program
    • Takeda Resource Groups
    • Medical checkups
    • Free vaccination program
    • Fitness Center

    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

    AUT - Wien - Industriestrasse 67

    Worker Type

    Employee

    Worker Sub-Type

    Regular

    Time Type

    Full time


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