UCB

QA Officer Drug Substance

Braine-l'Alleud

FULL TIME

November 18, 2024


Make your mark for patients

We are looking for QA Officer Drug Substance who is adaptable and has excellent communication skills to join our team based at our UCB campus located in Braine-l’Alleud, Belgium.



About the role:

You will play a role in ensuring the implementation and maintenance of an effective Quality Management System (QMS) in collaboration with your management. You’ll ensure all technical operations related to the manufacturing of pharmaceutical products (DS) comply with applicable national and international regulations and guidelines (GMP) as well as UCB Quality Policies.


What You’ll Do:

  • Ensure that intermediates and active pharmaceutical products are produced and released in accordance with UCB Quality Standards and applicable national and international regulations and guidelines (EMEA, FDA, PIC/S, ICH).
  • Manage product-related change control, failure investigations, deviations, qualification of dedicated equipment, cleaning validation, process validation, stabilities, CAPA, and action plans.
  • Review batch records from intermediates to drug substance and manage the batch disposition of chemical intermediates (DS manufacturing).
  • Drive the identification, development, and implementation of quality and operational excellence projects in response to business requirements, technical changes, identified risks, audit observations, and regulatory requirements.
  • Lead or co-lead internal audits to ensure compliance with internal standards and worldwide regulatory requirements with respect to c GMP.


Interested?

  • At least 3 years of experience in a regulated pharmaceutical environment or other life science or health-related field, including experience in Quality Assurance or Quality Control.
  • Experience with chemical/pharmaceutical production, development, and/or regulatory requirements, including knowledge of best practices in the pharmaceutical industry.
  • Experience with Quality Management Systems.
  • Strong interpersonal relationship and communication skills
  • Fluent in French and English


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 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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