QA Officer

작업 내용

To strengthen our Internal Manufacturing department, based in our Belgian site of Braine-l’Alleud, Belgium, we are looking for a talented individual to fill the position of “QA OFFICER Drug Substance.”

At UCB everything we do starts with a simple question: “How will this make a difference to the lives of people living with severe diseases?” We do that by connecting our ground-breaking science with patients and their families around the world living with the physical and social burdens of autoimmune and neurological disorders. Those connections offer new perspectives, drive innovation, and offer the hope of a new generation of therapies that will help improve lives on a global scale.

Would you like to work in an environment where you will be (with appropriate management) responsible for the implementation and maintenance of an effective Quality Management System?

As QA Officer, you:

• Ensure that all technical operations related to the manufacturing of pharmaceutical products (DS) comply with applicable national and/or international regulations and guidelines (GMP) & relevant UCB Quality Policies.
• Ensure that marketed pharmaceutical Products are manufactured and supplied in accordance with UCB Product Quality Standards.
• Pro-actively help operations to identify ,develop and implement quality and operational excellence improvements in response to business requirements, technical changes and regulatory requirements
• Drive continuous improvement projects that will allow risk reduction, improvement KPI and product quality

In this role, your scope of responsabilities will be to :

• Ensure that intermediates and active pharmaceuticals products get produced and released in accordance with UCB Quality Standards and applicable national and/or international regulations and guidelines (EMEA, FDA, PIC/S, ICH)
• Follow up of products, this includes :

- Change control

- Failure investigation

- Deviations (planned and unplanned)

- Qualification of dedicated equipment (protocols and reports)

- Cleaning validation of dedicated equipment

- Process validation (protocols and reports)

- Stabilities (protocols and reports)

- CAPA and action plans

• Review of batch record from intermediates to drug substance
• Batch disposition of chemical intermediates
• Review of master batch records and specifications
• Writing and follow up of Product Quality Review
• Follow up of RA commitments
• Authorization of technical transfer towards manufacturing (protocol and report)
• Authorization of re-tests for chemical substances

As a QA Officer, you take part in UCB continuous improvement strategy :

• You support the BTO Management to develop and implement technically robust and compliant Process and Equipment Support Systems allowing to exploit, maintain, monitor and continuously improve their operations
• You drive the identification of opportunities for improvement, development and implementation of quality and operational excellence projects in response to business requirements, technical changes, identified risks, audit observations and regulatory requirements at the Braine site.
• You lead or co-lead internal audits to ensure compliance with internal standards and worldwide regulatory requirements with respect to cGMP.
• Following a Risk Based Approach, you ensure that all BTO Systems, Processes, Operations and Activities are compliant with applicable regulations and guidelines (EMEA, FDA, PIC/S, ICH, best practices as defined by relevant organizations) and UCB Corporate Policies & Procedures hereby considering UCB objectives, plans and projects
• You promote quality and operational excellence and cultivate “Compliance Awareness”, “Continuous Improvement Attitude” & “Accountability Culture” across the BTO and related supporting services
• You ensure general cGMP training of internal customers
• You drive quality leadership and technical expertise on compliance strategy and interact with other functional areas to effectively communicate System & Process requirements
• You ensure communication of compliance status and issues to appropriate levels of the organization
• You ensure a relevant cGMP level regarding subcontractors used to support routine operations for BTO and related supporting services
• You participate in the preparation for regulatory inspections and provide direct support to System Owners and main customers during inspections

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

• You have a master’s degree in the following fields: chemical engineering, bioengineering, pharmacology, chemistry, biochemistry or industrial engineering in chemistry/biochemistry.
• You have at least 5 years in a regulated pharmaceutical environment or other life science or health related field, including experience in Quality Assurance or Quality Control
• You are experienced with chemical or pharmaceutical production, development and /or regulatory requirements, including knowledge production best practices in pharmaceutical industry
• You are experienced with Quality Management System and Auditing
• You can balance multiple priorities, provide leadership and prioritisation, and work with minimal supervision
• You are a fact-based decision maker with accountability and delivering attitude
• You show an excellent team player attitude with excellent interpersonal relationship and communication skills
• You have excellent oral and written communication skills
• You have excellent organization & coordination skills
• You are able to plan and direct the actions of a group of professionals and Quality Assurance personnel in multidisciplinary investigations / meetings
• You independently identify problem situations, communicate appropriately and initiate problem-solving process
• You can influence by persuasion
• You have good project management skills
• You are stress resistant
• You can make quality/compliance decisions in a business environment.
• You are fluent in French (Braine working language) and English (contact with global level, customers, and authorities)
• You can lead project teams and to motivate & inspire internal customers
• You are capable of independently resolve conflict situations
• You can independently identify, communicate, and initiate problem solving process, search for pragmatic solutions

Why you should apply

We can offer you an informal and open working environment that does not lock scientists into structure and hierarchy. Freedom to take space to pursue your own ideas and make a difference. Opportunity to gain internal and external visibility through interactions with other UCB teams and with world-renown academic investigators. Opportunity to grow both as a drug hunter and leader through participation in project teams and our career/personal development programs.

At UCB, we strive to attract passionate and outstanding talents who thrive on change and are ready to bring real value to patients. Working for us you’ll discover a place where you can grow and express your full potential. We place an emphasis on innovation, collaboration and impact. Through meaningful recognition and a motivating work atmosphere, we aim to provide an optimal experience by caring about and valuing our employees – just as we do for the patients we serve.

If you believe you are the perfect match to join us on our pioneering adventure, then we invite you to apply and tell us more about your profile and motivation.