Analytical Compliance Expert
Vienna, Vienna
vor 5 Tg.

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Job Description

As an Analytical Compliance Expert, you provide technical input and / or management of development programs by planning and executing unit operations.

In this role, you providesupport / trouble shooting during GMP release testing and stability, includingdata trending and analysisat vendor sites, vendor data management, support or leadership of OOS / ATI / Investigations, and regulatory filing support and use technical expertise to support and / or provide strategic guidance across multiple projects.

Accountabilities :

Works with departmental and / or cross functional peers to execute on assignments, including responsibility for program initiatives, under limited supervision.

Identifies topics for initiatives and contributes to local / global department initiatives.

As appropriate, data review and entry into database systems and verify content for regulatory submissions

As appropriate, assists in the planning of change control, manage and own change control in the respective system

Assists with the development of project strategy and communicates complex data / decisions within department and cross functionally as necessary

Serves as a technical resource for junior staff and leverages expertise in GMPs as a functional resource / trainer

Ensure QC requirements are met over life cycle of assigned clinical project including GMP release, stability, retest period extensions, reference standard re-qualifications, specification updates, method transfers, and method validations / verifications

Contributes to outsourcing strategy for department in conjunction with senior staff, including vendor audit and selection as needed

May lead local / global initiatives

Required Qualifications :

Ability to work at mid-level proficiency in a highly cross-functional and global team environment

  • Communicates progress or the status clearly and concisely within team and colleagues; documents issues and / or concerns concisely;
  • timely and effectively reports issues to supervisor or senior staff member(s).

    Ability to both generate and share knowledge within team and cross-functionally.

    Exercises mid-level time management and prioritization skills and is able to successfully manage multiple tasks simultaneously.

    Mid-level knowledge of and experience with analytical test methods, GMP and compliance requirements, stability, stability trending / statistics, and CMC requirements for IND, IMPD and other regulatory filings.

    Team player with a flexible personality but able to be persistent and assertive.

    Highly reliable, self-motivated, and have a curious personality open to learning and development.

    May have expertise outside of traditional program and / or initiative responsibilities (, expert in statistical analysis or stability, business system expertise / leadership / ownership or other relevant and appropriate responsibilities at an entry level.

    At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company.

    To do this, we empower our people to realize their potential through life-changing work. Takeda encourages and supports its employees by trainings, job rotations and mentoring.

    A balanced work life ratio (recognition for work and family, company kindergarten) and numerous benefits (fitness center, cafeteria, etc.

    complete our profile as a top employer.

    We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

    Gender, age, skin color, background or sexual orientation play no role in this as we actively promote diversity. We equally address people with disabilities.

    In the course of a recruitment process which is as free of barriers as possible, we encourage you to mention all relevant information in this context in your application.

    Motivated employees must be remunerated appropriately. The minimum salary for this important and responsible position is € ,92 gross per month (full time, collective wage agreement for the chemical industry).

    The actual remuneration package will be guided by your professional experience and your qualifications, so increased payment is possible.

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