Analytical Validation Specialist

null, Canton of Fribourg, ch
Company: UCB
Category: Architecture and Engineering Occupations
Published on 2021-06-22 04:11:02

Make your mark for patients.

We’re here because we want to build the future and transform patients’ lives for the better.

At UCB, our people are our experiences and achievements, our passion and drive. That’s why we’re looking for talented individuals with diverse backgrounds and experiences - not just the best and brightest, but those who care about making a meaningful difference in the lives of patients. We promote an environment of diversity, openness, and respect where people can make valuable contributions.

An exciting journey lies ahead. Will you join us in pushing the boundaries of what’s possible?

To strengthen our Analytical Validation team , as part of the Qualification and Validation department, based in our manufacturing site in Bulle, Switzerland , we are looking for a talented individual to fill the position of: Analytical Validation Specialist .

As an Analytical Validation Specialist you will bring analytical procedures into conformity following regulatory changes, the transfers of new methods, and the establishment of new monographs.

You like to work in an environment where you can:

  • Be part of an engaged and professional team.
  • Realise or supervise the execution of covalidation, transfer and verification protocols.
  • Participate in activities related to the Lifecycle of analytical methods.
  • You will contribute by:

  • Managing biological and non-biological analytical transfers between the different UCB laboratories or with CMOs and CLOs, as recipient or sender laboratory.
  • Reviewing and approving transfer or validation documents (protocols and reports).
  • Creating analytical verification documents (protocols and reports).
  • Planning and organize testing activities for AMTE activities.
  • Providing support to analyse test results.
  • Participating in investigations in the event of non-compliant results.
  • Ensuring the transfer of knowledge of methods to the laboratory as well as the necessary training.
  • Ensuring adherence to the schedule in terms of activities and resources.
  • Configuring methods in Empower as well as custom fields.
  • Writing, updating or reviewing analytical procedures, risk analyses and any other quality document.
  • I nterested? For this position you’ll need the following education, experience and skills :

  • Bachelor / master’s degree in Life Sciences / Biology/ Chemistry or equivalent.
  • Broad knowledge of cGMP governmental regulations and guidelines, and the ability to interpret and apply.
  • Experience of at least 5 years in an analytical laboratory (Biotech and / or Pharma).
  • Good knowledge of biological and chemical analytical techniques (HPLC, UPLC, GC, dissolution, UV, KF…) and compendial methods (Ph. Eur, USP).
  • Knowledge of ICH and regulatory guidelines.
  • Good knowledge of SDMS (Empower-Waters) and LIMS (Labware) systems.
  • Team Player.
  • Ability to communicate at all levels regarding quality matters.
  • In depth analytical thinking, statistical analysis, problem solving and technical investigation skills
  • Languages: Fluent in French, technical English.
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