Analytical Expertise & Validation Specialist

UCB

View: 101

Update day: 07-04-2024

Location: Bulle Fribourg FR

Category: Pharmaceutical / Chemical / Biotech

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Make your mark for patients


We are looking for an Analytical Expertise & Validation Specialist who is a strong communicator, structured and very well organized, to join us in our Business Acceleration Department, based in our site inBulle, Switzerland.

About the role
As an Analytical Expertise & Validation Specialist you will be managing the transfer, validation, and verification of analytical methods, ensuring compliance with procedures and regulatory requirements, while also providing expertise during investigations, Change Controls, projects, and presenting documentation in inspections and audits by health authorities and partners.

Who you’ll work with
Reporting to the Analytical Expertise & Validation Manager, you will be part of a team of 5 colleagues who works in a collaborative environment.

What you’ll do

  • Lead or participate in analytical AMTE/validation/equivalence activities and contribute to the global transfer strategy.
  • Author analytical procedures, risk analyses, and other quality documents, while also developing Custom Fields in CDS for new methods.
  • Contribute to equipment acquisition, write procedures, and provide training for new equipment, serving as a backup for troubleshooting.
  • Participate in continuous improvement of analytical documentation and processes, ensuring adherence to project planning and leading related projects.
  • Work according to cGMP requirements, complete required trainings, and lead/participate in deviations, investigations, CAPA, and Change Controls.
  • Actively apply HSE policy, promote HSE processes, and commit to UCB’s corporate responsibility ambitions.


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

  • A Bachelor’s or a Master’s degree coupled with minimum 4 years of experience in a QC department of a pharmaceutical or biological firm.
  • Profound understanding of cGMPs with expertise in analytical and instrumental chemistry/biochemistry (LC, GC, KF, UV, IR, etc.).
  • Confirmed experience in Empower system and software administration, coupled with strong leadership skills.
  • Fluent in both spoken and written French and English
  • Proficient in MS Office tools, and possesses basic knowledge of statistics.
  • Demonstrates the ability to define objectives, anticipate issues, identify priorities, make decisions, and exhibit a high capacity for problem-solving.


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 equitable 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 and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on on EMEA-Reasonable_Accommodation@ucb.com. Please note should your enquiry not relate to adjustments; we will not be able to support you through this channel.

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Deadline: 22-05-2024

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