MAKE YOUR MARK FOR PATIENTS

To strengthen our Pharma and Injectable Quality department we are looking for a talented profile to fill the position of: Supply QA Officer – Braine l’Alleud, Belgium

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
• Extensive experience between 5-10 years’ experience in the pharmaceutical/biotechnology sector
• Excellent oral and written communication skills in both French and English, with the ability to adapt to different situations
• Demonstrates a strong commitment to quality, reliability, and discretion
• Exhibits a team-oriented attitude with a collaborative spirit
• Maintains calmness under pressure and makes informed quality/compliance decisions in a business environment
• Shows a willingness to travel up to 20% of the time (Europe)
• Proactive problem-solving skills, with the ability to recognize, analyze, and resolve issues independently.
  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.

ABOUT THE ROLE

The Supply QA Officer assists the Supply QA team in establishing, implementing, maintaining and continuously improving, an effective Level of Quality linked to the supply chain activities, including purchasing/procurement and warehouses activities, on the Braine-L’Alleud site.

WHAT YOU WILL DO

• Ensure alignment with regulatory and cGMP/21 CFR expectations regarding following activities:
• Braine Campus and Braine Internal Manufacturing - Supply Chain in particular Vendor Management
• Braine Campus – Purchasing/Procurement
• Braine Campus - local production warehouses This consists in:
• Assisting in drawing up, review and approval of procedures and instructions related to these activities
• Being one of the QA representatives for those activities and departments on the Braine-L’Alleud site in case of alignment and level of quality related issues
• Treating alignment and level of quality related issues and follow up on the related corrective and preventive actions (via deviations handling, follow up of change control, initiation of investigation, follow up of complaints)
• Performing continuous GAP analysis between new expectations and Quality Management System documentation and between UCB documentation and actual practice (update Risk Register regularly)
• Ensure that Braine-L’Alleud suppliers and contract services organizations comply with all regulatory and cGMP/21 CFR expectations; this is achieved by:
• Performing supplier audits in order to evaluate their level of compliance with Quality Agreements, contract agreements, UCB Corporate Guidelines, and governmental regulations
• Ensuring that suppliers define corrective action plan, where needed
• Ensuring follow up of the implementation of corrective action plans
• Ensure the cold chain and controlled temperature process in order to maintain/ improve the GDP practice
• In response to business needs, identify and address potential non-compliance issues within the Quality Management System. Communicate these issues to QA and Braine internal manufacturing management, providing cGMP and QA expertise to support continuous improvement. Act as a QA representative during external audits for areas like Master Data, purchasing, vendor management, and warehouse operations
• Train UCB personnel regarding cGMP/21 CFR and Level of Quality requirements related to supply chain, purchasing, warehouse, operations, cold chain and SAP aspects.
• As SAP User, provide cGMP and QA expertise, interpretation and direction on SAP system enabling implementation of continuous improvement regarding specific domain of knowledge (Master Data, purchasing, vendors management)