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Supply Chain Business Process Expert
- Jefferson Wells
- Braine-l'Alleud
- Durée indéterminée, Indépendant
Analytical Development Sciences – Document Specialist
- Jefferson Wells
- Braine-l'Alleud
- Durée indéterminée, Indépendant
Bio Manufacturing Science and Technology (MSAT) Quality Lead
- Jefferson Wells
- Braine-l'Alleud
- Durée indéterminée, Indépendant
Research Scientist in Histology and Image Analysis for Neurodegenerative Diseases
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PRODUCTION MANAGER
- Derbigum
- Plusieurs régions
- Durée indéterminée
-
Avantages extra-légaux- Assurance groupe
- Voiture d'entreprise
- Chèques-repas
- Parking
- Eco Cheque
- Formations
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Bio Manufacturing Science and Technology (MSAT) Quality Lead
- Jefferson Wells
- Braine-l'Alleud
Contracting – Brabant Wallon
Bio Manufacturing Science and Technology (MSAT) Quality Lead
Description de la fonction
- Establish and build a network with the company key stakeholders in relation to Internal and External MSAT for Bio Drug Substances and Drug Products.
- Provide expert QA advice, support and management for technical operational QA and general QA matters associated with Internal & External Bio MSAT, with the following focus:
- Troubleshooting and ensure issues are resolved in accordance with policies and procedures
- Process improvement and life cycle management strategy within regulatory file boundaries
- Process industrialization and Technical transfers within commercial manufacturing facilities
- Complex investigations and CAPA plans implementation
- Process validation oversight and continuous process verification (CPV)
- Analytical method transfer and troubleshooting support.
- Build, establish and develop a governance model and process for Quality oversight of Internal and External MSAT for Bio Drug Substance and Drug Products which fosters continuous quality process improvement, optimized resource utilization and key indicator based performance monitoring
- Support assignments associated with the Products, or transversal projects across multiple Products
- Work closely with Global QA teams, Technical Operation Teams and Business stakeholders in an effective and efficient way
- Promote quality best practices throughout the External & Clinical Supply Quality team and where possible business stakeholders. Create as needed simplified, efficient processes and procedures to support the team’s activities.
- Provide support to other team members and assist in the further development of the wider team
- Work collaboratively as part of a wider team and when required deputise for the Head of Bio MSAT Quality and other Bio MSAT Quality Leads
- Support the review and approval of Regulatory Submission sections as needed
- Work in accordance with the company HSE and Corporate policy requirements and drive personal training and development activities to meet the needs of the business and professional career development
Profil
- Master’s degree in Sciences
- Fluency in French and English
- Knowledge in multiple areas of Biopharma incl manufacturing and analytical testing, including the interpretation and practical application of applicable regulations.
- Excellent knowledge of the Bioceutical industry from a business and technical perspective.
- Must have the ability to manage projects/ activities across global geographies within the area of expertise. Be capable of leading and motivating teams and demonstrate professional maturity in difficult situations. Set challenging objectives for self and others and drive for results.
- Must possess excellent interpersonal, verbal, and written communication skills at all levels internally and externally especially at senior management levels.
- Be able to coach/train/mentor colleagues and deliver training within area of expertise and assist with the development of top talent.
- Root cause and risk management/assessment skills Problem solving (Describe the level of “self-starting” thinking required in the for recognising, analysing and solving problems)
- Must have the ability to independently analyse data and information to draw conclusions and make effective decisions.
Offre
- Voiture d'entreprise
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, Afficher l'adresse e-mail
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À : Jefferson Wells | Braine-l'Alleud 1420
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