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Analytical Transfer & QC Readiness Expert

UCB
Greyerzbezirk, Freiburg
vor 4 Tagen

Make your mark for patients


We are looking for an Analytical Transfer & QC Readiness Expert who is eager to join us in our Patient Supply Quality Control department, based in our manufacturing site in Bulle, Switzerland.


About the role

As subject matter expert, you will ensure the transfer, validation, and verification of analytical methods in accordance with procedures, regulatory requirements, and user needs.

You will provide technical expertise in these areas during investigations, Change Controls, and projects, and manage post-transfer activities to ensure the compliance of new analytical methods.


What you’ll do

  • Lead/participate in activities linked to analytical AMTE / validation / compendial verification / equivalence in order to support the implementation of new product.
  • Participate to the global transfer strategy:
  • Write validation/verification/equivalence plans, protocols and reports,
  • Review transfer plans, protocols and reports.
  • Assess analyses and provide accurate and reliable results for AMTE / validation / Compendial verification / equivalence activities.
  • Write analytical procedures, risk analyses and any other quality document.
  • Configure instrument/report method in software (Chromatography Data System or standalone)
  • Implement methods and analytical knowledge in QC laboratory
  • Lead / Participate to deviations / Investigations / CAPA and Change Controls as SME for AMTE / validation / Compendial verification / equivalence activities.


I
nterested? For this role we’re looking for the following education, experience and skills

  • Education: Bachelor and/or master’s degree level in Chemistry/Life/Pharmaceutical Science.
  • Experienced in GMP environment
  • Practical knowledge of analytical techniques (HPLC/UPLC, GC, KF, RMN a plus).
  • Good knowledge of analytical software (Empower) and Lims.
  • Basic knowledge of statistics.
  • Good level of proficiency with MSOffice tools.
  • Excellent communication skills, for communicating with internal and external partners.
  • Excellent organization and problem-solving skills.
  • High level of autonomy and good stress management skills.
  • Solution-oriented and sensitive to customer needs.
  • Pragmatic and critical-minded.
  • Sense of responsibility, ownership and initiative.
  • Good level of spoken and written French and English are a must.
  • Team player.


Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you!

About us
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science.

Why work with us?
At UCB, we don’t just complete tasks, we create value. We aren’t afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected, and has equal opportunities to do their best work. We ‘go beyond’ to create value for our patients, and always with a human focus, whether that’s on our patients, our employees, or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.

UCB is an equal opportunity employer. All employment decisions will be made without regard to any characteristic protected by applicable laws.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on [email protected]. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.

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