QA Officer

We are looking for a self-motivated **QA Officer - Analytical Services / Quality Control **who is enthusiastic to join us in our **Quality Assurance, Braine Technical Ops **team, based in our UCB Campus located in **Braine-l'Alleud **in **Walloon Brabant **, **Belgium **.

**About the role**

Your main focus will be:

- the Quality Control operations related to physico-chemical, biological, microbiological, packaging & medical devices testing as well as injectable forms visual inspection,
- the Quality Control System activities including projects,
- the Processes & Systems to manage Analytical Testing, Specifications, Stability Studies, Analytical Ref. Standards, Analytical Method Transfers, etc.
- the quality support of interactions between internal Quality Control and external labs.

**Who you'll work with**

You will work in close collaboration with QC/QA Management, internal stakeholders and external laboratories.

**What you'll do**
- You ensure the quality oversight of QC laboratories and Analytical Operations to make sure these are conducted as per internal procedures, policies & applicable regulations.
- Using a risk-based approach, you ensure that all Braine QC and associated Analytical Operations are compliant to applicable regulations and guidelines (EMEA, FDA, PIC/S, ICH, best practices as defined by relevant organizations) and UCB Corporate Policies & Procedures.
- You pro-actively identify, (co-)develop and (co-)implement technically robust systems & process improvements in response to business requirements, technical changes and regulatory requirements.
- You develop and implement strategies that will assure the establishment and maintenance of a State of Compliance and a State of Control for Quality Control & Analytical Operations.
- You continuously improve Processes & Systems owned by Quality Control and related supporting services.
- You optimize the interaction between Braine Quality Control, Analytical Operations & supporting services (projects, processes, systems and documentation).

**Profil**:

- You have a master's degree related to the field of (bio-)pharmaceutical
- You have 5 years or more of experience in a regulated pharmaceutical environment or health related field, including 5 years' experience in Quality Assurance and/or Quality Control.
- You have experience with analytical laboratory operations, management systems and/or regulatory requirements, including knowledge of main analytical techniques used in the pharmaceutical industry
- You are experienced in analytical techniques and applicable regulations
- You are experienced with Quality Management System and Internal/External Auditing
- You can balance multiple priorities, provide leadership and prioritisation, and work with mínimal supervision
- You are a conceptual thinker
- You are a fact-based decision maker with accountability and delivering attitude
- You are a team player attitude with excellent interpersonal relationship and communication skills
- You have good oral and written communication skills
- You have excellent organization & coordination skills
- You can plan and direct the actions of a group of professionals and Quality Assurance personnel in multidisciplinary investigations / meetings
- You can independently identify problem situations, communicate appropriately and initiate problem-solving process
- You are able to 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 and English
- You can lead project teams and motivate & inspire internal customers