Internal Operations Quality Partner
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Make your mark for patients
To strengthen our External and Clinical Manufacturing Quality we are looking for a talented profile to fill the position of: Internal Operations Quality Partner – Braine l’Alleud, Belgium.
About the role
This position will support the manufacturing operational activities for UCB’s biological development projects.
You will work with
Internal Operations Quality Partner will closely collaborate and partner with various UCB teams, with a particular focus on working hand-in-hand with the Internal Bio Clin Manufacturing Team.
What you will do
· Work closely with Internal Bio Clin Manufacturing Team to ensure that the Quality Management System in support of product development and clinical supplies, work in a way that ensure product quality, safety and efficacy, meet regulatory requirements and expectations and operate in a fit for purpose and in a smarter way.
· Ensure quality review of master and executed batch records for drug substance supporting clinical trial studies
· Ensure specification review and release of materials used in the production of DS (Drug substance) for Clinical Trials
· Perform release of production intermediates
· Drive the continuous QA improvement process. Ensure adequate documentation processes and systems are available and followed for development projects (SOPs / Protocols / Report review).
· Plan and manage compliance tours and on the floor spot-check of the GMP area, offering quality assurance support including but not limited to inspection.
· Be partner with other departments to identify, mitigate and subsequently resolve compliance and quality issues (Investigations / deviations / out-of-specifications) that may affect UCB development activities and products.
· Support Change Control and perform the QA evaluation
Interested? For this position you’ll need the following education, experience and skills
· Bachelor’s, master’s degree or an education in a relevant scientific discipline
· Minimum of 5 years’ experience in GMP Environment.
· Fluent English communication (oral and written); any additional languages are a plus
· Solid understanding of the pharmaceutical biologics sector, including relevant technical elements of the business
· Experience with quality systems as deviations, CAPA, Change Controls.
· A good understanding of current regulatory requirements and expectations and an ability to interpret current regulations and requirements in the product development context is essential.
· Exhibit effective communication skills when interacting with stakeholders
· Capable of working independently and taking initiative
· Must be able to act in most circumstances without direct supervision and handle complex/urgent situations.
· On-site presence required (60%)
· Perform on-call duties during weekends and public holidays on a rotating basis.
· Experience with laboratory compliance and supplier qualification process is an asset
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
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