QA GMP Specialist

Job content

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 Global Quality Assurance department, based in our hub in Braine l’Alleud, we are looking for a talented individual to fill the position of: QA GMP Specialist

As a UCB QA GMP Specialist, you like to work in an environmentwhere you can:

• Support operational Quality Assurance activities for UCB’s biological development projects.
• Work closely with Technical Operations teams to ensure that all QA services for the project are provided in an effective and efficient way
• Provide advice and support on operational and general QA activities to UCB teams working on Drug Substance (DS) and Drug Product (DP) development, raw material release including excipient and critical consumable, compliance tour and audit preparation/participation.
• Closely partner with QA at UCB and vendor sites, and collaboration with UCB Technical Operations and other UCB teams.
  

As a UCB QA GMP Specialist, you willcontribute by:

• Review and approval of manufacturing and disposition documentation, for example:
• Manufacture including in-process analytical testing (process description, master batch records, specifications, certificates…)
• Quality Agreements
• Process development studies (including holding times, filter validation, impurities clearance, extractable/leachable, material of contact, shipping qualification, validation summary reports)
• Protein characterization
• Mammalian working cell banks (preparation, testing, characterization)
• Deviations, Change controls, CAPA
• Product impact assessment related to system implementation/improvement
  

Such Review Will Include

• Check of referenced documents and data
• Compliance with relevant protocol, SOP or GMP guideline
• Compliance with regulatory guidelines
• Deviations and changes are properly addressed and documented
• Consistency with other documents
• Discussions and conclusions are pertinent and consistent with data
• Comments from review are correctly addressed
• Review and approve DS and DP CMC submission sections
  

Such Review Will Include

• Consistency with supportive documents
• Consistency with other sections
• Comments from review are correctly addressed
• Content is in line with relevant regulatory guideline
• Work closely with Technical Operations teams to ensure that all QA services for the project are provided in an effective and efficient way.
  

Interested? For this position you’ll need the following education, experience and skills:

• Minimum of 5 years working in the pharmaceutical biologics industry in a quality assurance position. Operational GMP experience would be a distinct advantage.
• Must be knowledgeable in several areas of the global pharmaceutical industry, including the interpretation and practical application of applicable regulations together with quality principles and techniques.
• Experienced in one or more of the following:
• regulatory submission preparation for biological products
• ICH Q2 analytical method validation principles and general analytical techniques
• GMP process validation
• DS and/or DP process manufacture for biological products
• Demonstrate initiative and an ability to help team and others solve problems creatively
• Ensure free flow of information to the appropriate stakeholders
• In-depth knowledge and understanding of applicable regulations, quality principles, relevant business processes and techniques
• Good background knowledge of the pharmaceutical biologics industry and applicable technical aspects of the business
• Understand practical applications of GMP, compliance principles and theories incl. risk management
• Problem solving:
• Identify risks and proposes corrective actions in complex situations
• Apply appropriate strategies and option-based rationale
• Apply best practices, principles and theories in moderately complex situations and issues
• Give input based on expertise and awareness of business implications
• Demonstrate initiative and an ability to help team and others solve problems creatively and practically Implements risk-based approach
• Take innovative approach to working practices
  

About Us.

UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 7,600 people in all four corners of the globe, inspired by patients and driven by science.

At UCB, everything we do start with a simple question: “How will this create value for people living with severe disease?”. We are on a journey to become the patient-preferred biopharma leader by delivering medicines and solutions that improve lives. We want to ensure the creation of patient value, now and into the future, while contributing to a society where a population of 8 billion people and more should be able to live a good life within limited resources of one planet.

Curious to know more? Please visit our website www.ucb.com .

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.