Validity Specialist (temporary for 2.5 years)
F. Hoffmann-La Roche Ltd
Basel Headquarter,Basel-City,Switzerland,
vor 1 Tg.

Behind every presentation of each product sold by Roche is the involvement of Pharma Global Technical Operations (PT). Starting with Phase I of the development process and continuing through to product maturity, PT makes medicines at sites around the world and includes more than 10 000 employees worldwide.

As Validity Specialist you are part of the Global Stability Program Management Team in Pharma Technical Operations in Basel.

We are dedicated to ensuring validity change requests are handled correctly and in a consistent manner so the assignment of a product's shelf life, storage statement, and overall stability budget is scientifically confirmed based on available stability data.

Furthermore we handle the validity data in ValDaM so to ensure the correct stability information is visible to internal and external partners for daily business needs.

Validity is the time span and under which storage conditions Product X, in the specific primary packaging remains within specification.

In summary it is the generic term for shelf-life and storage remark for Roche products.

The Validity Specialist is handling global validity assignments and is managing and coordinating the work of the Validity Commission (global board).

Furthermore, this role is providing validity management and related project support and advice.

As Validity Specialist you will :

  • Convene and chair the Validity Commission meetings for the assignment of validities (shelf life and storage statement) and related stability items to Roche products.
  • You will be accountable for smooth operation and effective organization of the Validity Commission

  • Subject Matter Expert (SME) and Single Point of Contact (SPOC) for all validity related questions and issues. You will act as Face to the Customer for Validity requests, and you will be the interface to members of the Validity Commission, internal and external partners
  • Ensure that all validity change requests are complete and coherent, are handled and assessed according to the established Roche change control process, and the decisions are communicated and documented (TrackWise).
  • You will ensure a consistent approach (process, decisions, documentation, tools) for stability information related to validity across the Roche product portfolio

  • Coordination within the ValC-team to ensure smooth Validity Commission operation within the Business Process, including submitted requests and their resource assignments, ValDaM data entry and data maintenance, and ValC meeting activities
  • Act as ValDaM database Administrator. This includes the maintenance and update of ValDaM holding shelf-life information of finished and bulk products.
  • You will support the further development of ValDaM in response to further needs and requirements

  • For global submissions : provide guidance about validity to global teams and functional areas. You will give input to TRIC cases concerning shelf life and storage remarks
  • ValDaM is a database containing the scientifically ensured validities of all global drug products and APIs for the different available packaging configurations in relation to the climatic zones.)

    You have a Master Degree in Life Sciences or equivalent and you bring 5-10 years of professional experience in the Pharmaceutical Industry as a Production Manager, Quality Assurance / Control Manager, or Stability Specialist.

    You bring the following skills and competencies :

  • Shown leadership in matrix organizations. Guides and develops teams effectively by adhering to established modes of behaviour and action
  • Strong communication skills; proficient influencing and convincing skills
  • Good business relationships; excellent stakeholder management skills. Networked mindset
  • Continuous improvement; bring forth new ideas that improve the status quo whilst identifying and eliminating waste.
  • For questions please call the Recruiting Team Switzerland : +41616822550

    Roche is an equal opportunity employer.

    Quality Assurance

    Roche is an equal opportunity employer.

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