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Analytical Development Sciences – Document Specialist
- Jefferson Wells
- Braine-l'Alleud
- Onbepaalde duur, Zelfstandige
Bio Manufacturing Science and Technology (MSAT) Quality Lead
- Jefferson Wells
- Braine-l'Alleud
- Onbepaalde duur, Zelfstandige
Research Scientist in Histology and Image Analysis for Neurodegenerative Diseases
- Jefferson Wells
- Braine-l'Alleud
- Onbepaalde duur, Zelfstandige, Starter
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- Onbepaalde duur
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Quality System Contractor
- Jefferson Wells
- Braine-l'Alleud
Contracting – Brabant-Walloon
Quality System Contractor
Functieomschrijving
- Ensure the promotion of awareness of applicable regulatory and quality management system throughout the Braine Bio DS staff.
- Support network initiatives related to quality and compliance for local implementation; act as connection for global initiatives related to quality and compliance for local implementation (including Regulatory Intelligence Network RIN).
- Benchmark with external sources to understand industry trends and share with the department.
- Serve as a quality and technical mentor/coach for interpretation and application of regulatory and global requirements for the Braine Bio DS staff.
- Lead and model behaviors foundation to strong Quality Culture with connection to operations (e.g., build training materials based on deficiencies noticed during gembas, etc.).
- Ensure that adequate quality governance boards are implemented and provide direction (e.g., deviation review board, change control review board, etc.).
- Develop appropriate tools to collect quality-related risks and ensure escalation as per companies quality management system.
- Chair the Quality Council; develop relevant indicators to assess maturity level and propose action plan to ensure continuous improvement and improve Quality Culture.
- Clarify roles and responsibilities and interactions with other functions involved in QMS. Ensure the voice of the Bio DS Quality Belgium team is accounted for.
- Lead inspection readiness program.
- Coordinate inspections or audits by regulatory authorities, companies Global Quality Auditing team, and others as needed (including development of responses).
- Identify opportunities for process improvements and lead initiatives to enhance quality and efficiency.
- Implement best practices and innovative solutions to improve product quality and operational performance.
- Make connection within companies organization to improve visibility and influence of the team (e.g., quality systems & strategy, internal manufacturing quality, global quality auditing).
Profiel
- Minimum of 10 years’ experience in the pharmaceutical industry.
- Demonstrated experience in quality system / quality compliance.
- Demonstrated experience in audit and inspection.
- Ability to collaborate and influence across departments and levels.
- Fluent in French and English.
- On-site presence required.
- Additional Skills: Demonstrated experience in biological drug substance (business and/or quality) to facilitate interactions with other teams. Ability to face unstable environment and demonstrate agility to handle unpredicted changes. Stress resistant.
Aanbod
- 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
Bereken je reistijd
Naar : Jefferson Wells | Braine-l'Alleud 1420
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