Quality Systems Officer Utilities

il y a 3 jours

Anderlecht, Belgique U C B Temps plein

We are looking for a **QA Systems Officer **to join us in our **QA Systems & Continuous Improvement Team **team, based in our UCB Campus office in Braine-l'Alleud, Walloon Brabant, Belgium.

**About the role**:

- You promote Quality and Operational Excellence and cultivate "Quality Culture", "Compliance Awareness", "Continuous Improvement Attitude" & "Accountability Culture" across the UCB teams.
- You drive Quality Leadership on Quality & Compliance Strategy and interact with other functional areas to effectively communicate system & process requirements.
- You are maintaining and continuously improving the Quality Management System and related processes.
- You ensure continued compliance of the QMS to applicable regulations and guidelines, UCB Corporate Policies & Procedures, UCB objectives, plans and projects.

**Who you'll work with**:
You we be a part of the Quality Assurance department within the Quality Systems & Continuous Improvements team organization and will be in cooperation with Braine Technical Operations (BTO) and related supporting services

**What you'll do**:

- Using a Risk Based Approach, ensure that all Utilities, HVAC & Cleanroom Systems used by Braine Technical Operations and related supporting services are compliant with applicable regulations and guidelines (EMEA, FDA, PIC/S, ICH, best practices as defined by relevant organizations) and UCB Corporate Policies & Procedures.
- Cultivate a "Compliance Awareness Culture" across the BTO department and related supporting services.
- Ensure communication of compliance status and issues to the appropriate levels of the organization
- Ensure a relevant cGMP level regarding subcontractors used to support routine operations for BMO and its supporting services.
- Participate in the preparation for regulatory inspections and provide direct support to System Owners and main customers during inspections.
- Support the System Owners to develop and implement technically robust and compliant Systems allowing to continuously improve their operations.
- Responsible for all cGMP aspects related to the Utilities, HVAC & Cleanroom Systems owned by the System Owner.
- Drive quality leadership and technical expertise on Utilities, HVAC & Cleanroom Systems compliance strategy and interact with other functional areas to effectively communicate System requirements.
- Encourage and assist in the development of remediation and mitigation plans for Utilities, HVAC & Cleanroom Systems & Projects to ensure that they meet policies, procedures, and regulatory requirements.
- Establish and/or assist in the establishment of policies, procedures and standards for UCB consistent with pertinent government regulations and procedures.
- Assure that the Utilities, HVAC and Cleanrooms operate in accordance with UCB Quality Standards and applicable national and/or international regulations and guidelines (EMEA, FDA, PIC/S, ICH)
- Together with the Utilities, HVAC & Cleanroom System Owners, ensure direct follow of Compliance Audit activities, Deviations, Planned Deviations, Failure Investigations and Change Control related to the Utilities, HVAC & Cleanroom Systems
- Ensure cGMP training related to Utilities, HVAC & Cleanroom activities
- Ensure follow-up and communication to QA Manufacturing teams of Deviations, Planned Deviations and Change Control related to Utilities, HVAC & Cleanrooms that could have an impact on manufactured batches
- Support the Qualification & Validation activities for Utilities, HVAC & Cleanrooms and perform QA approval and QA authorization of related documentation.
- Participation to the digitalization improvement program

**Profil**:

- You have a master's degree in engineering or sciences preferred
- You are experienced in a regulated pharmaceutical environment or other life science or health related field is mandatory
- You have experience with Quality Management Systems and Auditing is an asset
- You are fluent in French and have a very good level in English
- You have an affinity for Quality & Compliance and worldwide regulations pertaining to cGMP regulations pertaining to Pharmaceuticals & Medical Devices
- You can balance multiple priorities
- You are a fact-based decision maker with accountability
- You are a team player with good interpersonal relationship and communication skills
- You have good oral and written communication skills
- You are capable of independently identifying problem situations and initiating problem solving

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