QA Equipment and Data Integrity Partner

il y a 3 semaines

Brainel'Alleud, Belgique UCB Temps plein

**Make your mark for patients**

To strengthen our **QA Systems & Continuous Improvement Team**, based** **in **Braine, Belgium** we are looking for a talented individual to fill the position of**:QA Equipment and Data Integrity Partner.**

According to QA S&CI team organization and in cooperation with Braine Technical Operations (BTO) and related supporting services, **the main responsibilities** of the position are:
**General QA Role**:

- 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

**Equipment and Data Integrity Partner**:

- The Equipment and Data Integrity Partner will be responsible for the administration of the BTO Manufacturing department's computerized systems and compliance with regulatory requirements.
- She/he works closely with the manufacturing teams who own the systems. He/she ensures the link between the users' needs concerning the day-to-day use of the systems and the system administration and requirements.

**Main Tasks are**:

- Prepare and execute, in partnership with colleagues, the annual program of periodic review of Braine Manufacturing's computerized equipment
- Data Integrity Risk Assessment
- Reconciliation of accesses
- Participates in new equipment projects in collaboration with the Business Project Manager, the Qualification / Validation, Metrology / Maintenance and IT teams.
- Coordinates the Data Integrity Risk Assessment (DIRA)
- Participates in the resolution of identified GAPs
- Define audit trail review strategy
- Ensures the security of raw data, recipes and parameters by proposing adequate backup and security.
- Data flow Diagram
- Owner of equipment administration procedures
- Creates the administration document, definition of security levels and privilege
- Access management, process definition
- Maintains the list of equipment, and associated procedure
- Incident management: ensures the management of incidents concerning the software’s system such as data backup, system access problems, etc.
- Continuous improvement
- Shop floor to perform spot-checks on systems, audit trail,...
- Participation on projects: Digitalization Partner

**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

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

- Master Degree
- Hight affinity and resourceful with IT systems
- Experience in a regulated pharmaceutical environment or other life science or health related field is preferred
- Experience with Quality Management Systems and Auditing is an asset
- Fluent in French, very good level in English are required
- Affinity for Quality & Compliance and worldwide regulations pertaining to cGMP regulations pertaining to Pharmaceuticals & Medical Devices
- Capability to work with mínimal supervision in order for instance to resolve conflict situations with supplier
- 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
- Capable of independently identifying 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.

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.

**Why work for us?**
At UCB, we don’t just complete tasks, we create value. We aren’t afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring,

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