QA Systems Officer
il y a 2 jours
**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 **QA Systems & Continuous Improvement (S&CI) Team**, based** **in **Braine-l’Alleud (Belgium)**, we are looking for a talented individual to fill the position of**:QA Systems Officer**
According to the Associate Director’s instructions, QA S&CI team organization and in cooperation with Braine Technical Operations (BTO) and related supporting services, **the main responsibilities** of the position of QA Systems Officer are:
**General QA**:
- Promote Quality and Operational Excellence and cultivate “Quality Culture”, “Compliance Awareness”, “Continuous Improvement Attitude” & “Accountability Culture” across the UCB teams.
- Drive Quality Leadership on Quality & Compliance Strategy and interact with other functional areas to effectively communicate system & process requirements.
- Maintaining and continuously improving the Quality Management System and related processes.
- Ensuring continued compliance of the QMS to applicable regulations and guidelines, UCB Corporate Policies & Procedures, UCB objectives, plans and projects.
**Supplier Evaluation Program & Audit Management**:
- Implementing and maintaining efficient UCB supplier’s evaluation process for equipment, consumables and services.
- Leading or co-leading internal audits (in Braine) and supplier audits (paper based/survey) to ensure compliance with internal standards and worldwide regulatory requirements with respect to GMP.
- As QA for the Supplier Evaluation Program, providing the information requested by the auditors during external audit and inspection in Braine.
- Management of Deviation, Investigation and CAPA related to the supplier evaluation activities.
- Fronter during audit & inspection to facilitate audits and inspections planned in Braine.
**Pest control**:
- Organizing and coordinating the GMP implementation of Pest control for the entire manufacturing site.
- Management of Deviation, Investigation and CAPA related to pest control activities.
**Environmental monitoring**:
- Support QA Utilities/Facilities with SQR creation and preparation of trending reports.
- Management of out of specifications deviations.
**Continuous Improvement**:
- Drive the identification of opportunities or improvement.
- Develop, drive and/or implement quality improvement and operational excellence projects in response to business requirements, observed issues, technical changes, identified risks, audit observations and changing regulatory requirements.
**Digitalization**:participation to the Digitalization Improvement Program.
**Interested? For this position you’ll need the following education, experience and skills**:
- Master’s Degree preferred (Bachelor’s Degree with significant experience may be sufficient).
- Experience in a regulated pharmaceutical environment OR other life science OR health related fields is mandatory.
- Experience in Quality & Compliance and worldwide regulations pertaining to cGMP regulations is required.
- Experience with Quality Management Systems and Auditing is an asset.
- Affinity with IT systems.
- Very good command in French AND English (both written and spoken).
Soft skills:
- Able to work with mínimal supervision in order to resolve conflict situations with suppliers.
- Ability to balance multiple priorities.
- Fact based decision maker with accountability.
- Team player with good interpersonal relationship and communication skills.
- Good oral and written communication skills.
- Able to independently identify problem situations and initiating problem solving.
**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.
**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 peopl
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