Vacature QA Systems Officer – Utilities in Braine-l'Alleud

Contracting – Brabant Wallon

QA Systems Officer – Utilities

Functieomschrijving

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, the company Corporate Policies & Procedures, objectives, plans and projects.

QA Systems Officer on Utilities, HVAC & Cleanroom Systems & Operations:

Using a Risk Based Approach, ensure that all Utilities, HVAC & Cleanroom Systems used by the campus and related supporting services are compliant with applicable regulations and guidelines (EMEA, FDA, PIC/S, ICH, best practices as defined by relevant organizations) and the company Corporate Policies & Procedures.
Cultivate a “Compliance Awareness Culture” across the manufacturing 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 the Braine Manufacturing site 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 the company consistent with pertinent government regulations and procedures.
Assure that the Utilities, HVAC and Cleanrooms operate in accordance with the company 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.

Profiel

Master Degree in engineering or sciences preferred
Experience in a regulated pharmaceutical environment or other life science or health related field is mandatory
Fluent in French, very good level in English is required
Affinity for Quality & Compliance and worldwide regulations pertaining to cGMP regulations pertaining to Pharmaceuticals & Medical Devices
Team player with good interpersonal relationship and communication skills

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Bedrijfswagen

Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply or send me your CV, Toon emailadres

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Naar : Jefferson Wells | Braine-l'Alleud 1420

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Functietype:

Quality manager

Sector:

Chemie en Pharmacie

Standplaats

Braine-l'Alleud

Vereisten

Master (Licentiaat; Universiteit of Hoger Onderwijs Lange Type) Frans

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QA Systems Officer – Utilities

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Functieomschrijving

Profiel

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QA Systems Officer – Utilities

QA Systems Officer – Utilities

Functieomschrijving

Profiel

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