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Let's push the boundaries together and make the most of your talents!

QA Officer

Location: 

Braine L'alleud, Walloon Brabant, Belgium

Job Function:  Quality Assurance
Job ID:  70307

Help us transform patients' lives.

At UCB, we put our heart, soul, and skills into making a difference for people living with severe disease. Working together to push the boundaries, we blend the best of our talents to unlock innovation.  Will you join us in our pioneering adventure?

 

 

To strengthen our Chemical QA Manufacturing Team, based in Braine, Belgium we are looking for a talented individual to fill the position of: QA Officer Drug Substance.

 

As QA Officer Drug Substance, together with appropriate management, you will be responsible for the implementation and maintenance of an effective Quality Management System on the UCB Braine Site. This means more precisely:

  • To assure 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.
  • To assure that marketed pharmaceutical Products are manufactured and supplied in accordance with UCB Product Quality Standards.
  • To help operations identifying, developing and implementing quality and operational excellence improvements in response to business requirements, technical changes and regulatory requirements.
  • To drive continuous improvement projects that will  allow risk reduction, improvement KPI and product quality.

 

You will contribute by:

  1. OPERATIONAL QA ROLE
  • Assure 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 product related: 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 (DS manufacturing).
  • 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 (DS manufacturing).

 

  1. CONTINUOUS IMPROVEMENT
  • 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.
  • 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.
  • Lead or co-lead internal audits to ensure compliance with internal standards and worldwide regulatory requirements with respect to cGMP.
  • Using a Risk Based Approach, 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.
  • Promote quality and operational excellence and cultivate “Compliance Awareness”, “Continuous Improvement Attitude” & “Accountability Culture” across the BTO and related supporting services.
  • Ensure general cGMP training of internal customers.
  • Drive quality leadership and technical expertise on compliance strategy and interact with other functional areas to effectively communicate System & Process requirements.
  • Ensure communication of compliance status and issues to appropriate levels of the organization.
  • Ensure a relevant cGMP level regarding subcontractors used to support routine operations for BTO and related supporting services.
  • Participate in the preparation for regulatory inspections and provide direct support to System Owners and main customers during inspections.

 

  1. BACK-UP FUNCTION: the position can act as back-up for his direct colleagues or for the Associate Director QA  Chemical manufacturing according to the Associate Director’s instructions and after appropriate training.

 

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

 

  • Master’s Degree in chemistry, biochemistry, chemical engineering,…
  • At least 5 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 production best practices in pharmaceutical industry is required.
  • Experience with Quality Management System and Internal/External Auditing
  • Excellent command in French (Braine working language) and English (contact with global level, customers and authorities)

 

Soft skills:

 

  • Ability to balance multiple priorities, provide leadership and prioritisation, and work with minimal supervision
  • Fact based decision maker with accountability and delivering attitude
  • Excellent team player attitude with excellent interpersonal relationship and communication skills
  • Excellent organization & coordination skills
  • Ability to plan and direct the actions of a group of professionals and Quality Assurance personnel in multidisciplinary investigations / meetings
  • Independently identify problem situations, communicate appropriately and initiate problem solving process, search for pragmatic solutions
  • Ability to influence by persuasion
  • Stress resistant

 

Why you should apply?

 

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.

 

About us.

UCB- Inspired by Patients. Driven by Science. Everything we do starts with a simple question: “How will this create value for people living with severe diseases?” By putting patients at the heart of what we do, our approach – from discovery to development to delivery – is continuously transformed and designed around patient needs and their journey.

With a team of approximately 7,500 employees and operations in more than 40 countries, we are a global biopharmaceutical company investing more than a quarter of our revenue in cutting-edge scientific research. We are focused on addressing chronic, neurological, immunological, and bone diseases.

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. 

Apply now »