Collecte des besoins pour rédaction de VP/VSR (plans de validation / Validation Summary Report)
Interaction avec des Unités de production pour revoir les attentes et planning en cours (coordination et gestion de meetings Hebdomadaires)
Collecte des informations pour réaliser un assessment Validation pour les changements process identifiés et rédiger les plans de Validation
Rédiger, suivre processus documentaire, corriger des VP et VSR dans le système KNEAT
Donner un statut régulier sur l'état d'avancement des actions
Utilisation de KNEAT, SAP, Windows.
Votre profil ?
Formation scientifique (ingénieur, pharmacien, master scientifique ou équivalent)
Expérience confirmée en validation dans l’industrie pharmaceutique
Expérience sur la rédaction de VP/VSR
Formation des exigences qualité et validation proces
Connaissance des activités de validation process (bulk)
Très bonne maîtrise des systèmes documentaires électroniques (KNEAT indispensable)
Connaissance de SAP est un plus
Français courant – Anglais professionnel
Excellentes capacités de communication et de coordination
Sens de l’organisation et respect des délais
Notre offre ? Nous vous offrons un contrat à durée indéterminée ainsi qu'un package salarial attractif. Vous profiterez également de l'opportunité de vous développer personnellement et professionnellement à travers des formations internes. Intéressé(e) ? Postulez directement via notre site WWW.JEFFERSONWELLS.BE ou envoyez votre CV à l'adresse mail suivante [email protected]
Construction Manager Brabant Walloon – contracting Our partner is looking for a Construction Manager to join its team. This international company is well-known for its pharmaceuticals. Your responsibilities?
Coordinate construction activities and liaise with the Host Site EHS team
Review safe methods of working ahead of work starting
Lead daily safe work planning sessions e.g. SPA, RAMS, PTW
Participate in daily prestart workforce safety briefings
Participate in safety meetings and lead daily safety walks of the site
Participate in toolbox talks
Assist in incident investigation
Induct / orientate the workers
Identify and control new workers
Identify general and specific safety hazards to the workers
Inspect and conduct safety audits of tasks and safe systems / processes
Ensure that all incidents are reported
Participate in incident investigations
Ensure workers only carry out tasks for which they are trained and qualified
Ensure risk assessments and method statements are in place and in use
Encourage and participate in the behavioral safety system
Intervene and correct any unsafe conditions
Participate in safety meetings
Ensure good housekeeping and organised tidiness (5S) at all times
Your profile?
Experience in construction management of medium and large capital projects
EHS experience
Project and people management skills with thorough knowledge of construction
Communication and collaboration skills
Our offer? Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to training in technical matters and soft skills. We will be your career partner for each step along the way.
Validation Engineer Brabant Walloon – contracting Our partner is looking for a Validation Engineer to join its team. This international company is well-known for its pharmaceuticals. Your responsibilities? The department is, amongst other expertise, in charge of the implementation of health authorities Facility Design requirement for all manufacturing building in the Belgium sites. A new task is required : implementing internal standards of the company (Engineering Standard) You will be responsible for leading the implementation of this new standard in several steps :
Gap analysis between Engineering Standard and Belgium SOP’s
Support and lead risk assessment issuing for each unit with local SMEs
Follow up and track progress on assessment issuing as per milestone.
Participating in the assessment to standardize inter manufacturing units evidences and assessment (same answer for requirement, adding and suggest control or mitigations, identifying gaps).
Possibly, support the Unit to edit remediation plans for gaps identified.
Furthermore, the candidate leads the reporting to Engineering Standard Duty holder and sponsor.
Your profile?
Scientific university degree (Engineer in Chemistry, biochemistry, or Pharmacist,…)
Experience in Product & Process
Experience in project management
Risk assessment
Successful experience in stakeholders management
Excellent organization skills and ability to operate effectively in a multicultural, matrix organization where the workload requires balancing multiple responsibilities simultaneously
Fluent in French et English
Our offer? Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to training 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. Do you have any questions? You can contact Anaïs Malikian, [email protected]
