• Location: Braine l'Alleud
• Type: Contracting
• Job #19854

Technicien QC – IPC

#Contracting #Brabant Wallon #Shift

Pour son laboratoire de contrôle qualité, notre partenaire est à la recherche d’un technicien analyste dont la fonction consiste à la réalisation et l’évaluation des analyses des échantillons issus de la production et d’autres départements.

Votre mission?

• Mettre en œuvre et interpréter les analyses d’échantillons devant être pris en charge par le laboratoire ainsi que les documents associés (RE, CAPA, OOS, NCP, …)
• Participer au transfert et à la validation de méthodes analytiques.
• Participer aux interventions, aux maintenances planifiées et qualifications des appareils analytiques.
• Participer à la maintenance du laboratoire.
• Rapporter les déviations des processus analytiques, les problèmes techniques et exécuter les actions correctives.
• Participer à la formation des nouveaux analystes.

Votre profil?

• Vous avez un bachelier en Chimie
• Vous avez une expérience relevante en HPLC et en laboratoire QC en industrie pharmaceutique (GMP)
• Vous avez une expérience en validation de méthodes analytiques HPLC (GC); utilisation du KF (Karl Fischer) et de la GC
• Vous avez une grande rigueur, une bonne organisation, et un excellent esprit d’équipe

Ce que nous vous offrons ?

Un CDI avec un package salariale correspondant à votre expérience et compétences. L'opportunité de développer vos compétences au sein d'un grand groupe pharmaceutique de renommée international.

Ce poste vous intéresse? Si vous avez des questions n'hésitez pas à contacter Sophie Rolis [email protected]

• Location: Braine l'Alleud
• Type: Contracting
• Job #19748

Vendor Quality Support

Brabant Wallon – contracting

Our partner is looking for a Vendor Quality Support to reinforce its team. This international company is well-known for its research, development, and marketing of pharmaceutical and vaccines

What are your responsibilities?

• Review annual stability protocol and reports. Communicate any trends to the Vendor Quality Lead (VQL).
• Perform review of CMO PQR within agreed timeframe, complete PQR Assessment
• Participate to Quality Agreements (QAA) periodic reviews and draft QAA according to available templates.
• Perform stakeholder review of various change controls, support change control preparation, keeping change control trackers up to date accordingly.
• In specific cases, review Validation and Technical Transfer protocols and reports liaising with VQL.
• Review Master Batch records changes linked to change controls or to support initiation.
• Investigations/deviations/ out-of-specifications. Perform the QA review of deviation notifications, retrieve and collect supportive information from involved stakeholders to allow and perform assessment.
• If needed work with the Vendor Quality Lead, the Vendor team and Global Quality Lead to determine the Root cause of issues which may lead to a Technical meeting. Coordinate vendor quality related investigations.
• Support Audits preparation at our partner or at the vendors
• Support Risk based evaluation of the vendors in collaboration with VQLs.
• Provide expert QA advice, support and management for technical operational QA and general QA matters associated with the assigned products and activities at the vendors.
• Address CMO Connectivity Fail messages and coordinate resolution of issues internally and with appropriate vendors. Ensure regular update of relevant guidance.
• Quality Complaints: Perform trend, recurrence analysis with the Central Complaint Unit, escalating issues to VQL.

Who are you?

• You hold a bachelor’s degree (or master’s degree) in a Scientific orientation
• You have 5 to 10 years professional experience & knowledge in a Quality role in the pharmaceutical industry preferably in the GMP operations environment
• Hands-on field experience in failure investigations, root cause analysis, deviation review
• Solid knowledge about European Good Manufacturing Practices (Eudralex Vol. 4)
• You are fluent in English

What can you expect?

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. Do you have any questions? You can contact Sophie Rolis : [email protected]

• Location: Braine l'Alleud
• Type: Contracting
• Job #19745

QC Analyst

Brabant Wallon – contracting

Our partner is looking for a QC Analyst to reinforce its team. This international company is well-known for its research, development, and marketing of pharmaceutical and vaccines

What are your responsibilities?

This team’s primary responsibility is to perform release and stability testing according to the required GMP and regulatory standards of our client from early clinical phases to phase III. Here are your responsibilities:

• Perform daily laboratory activities related to release and stability testing
• Analyze results
• Verify data (double check)
• Work with other analysts in organizing the release and stability analyses of the laboratory
• Follow up deviations, incidents and validate the results within a LIMS system.
• Support the implementation of the pharmacopeial testing by evaluating new product or techniques
• Support investigation with the team or with the commercial QC

Who are you?

• You hold a bachelor degree (or master’s degree), in biochemistry or in analytical chemistry
• A good experience and expertise in pharmacopeia testing as particles matter measurement, appearance of product, osmolality, pH, water content, etc.
• A good knowledge of GMP standards in QC laboratory
• Good interpersonal, verbal, and written communication skills with ability to balance multiple priorities
• Good knowledge of English (ability to read scientific documents)

What can you expect?

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. Do you have any questions? You can contact Sophie Rolis : [email protected]

• Location: braine l'alleud
• Type: Contracting
• Job #19597

Scientist Regulatory Bioanalysis

Brabant Wallon – contracting 

Our partner is looking for a Scientist Regulatory Bioanalysis to join its team. This international company is well-known for its pharmaceuticals and vaccines. 

What are your responsibilities?

You will Be responsible as a lab-based scientist for effective method validation and sample testing activities across multiple projects in the Immunology and CNS therapeutic portfolios. You will contribute by:

• running validation, and sample testing experiments.
• delivering needs for pre-clinical and clinical studies
• Work with method development scientists for the successful transfer of assays.
• maintenance of the GLP quality system as well as being involved in optimizing and reshaping the quality system as a function of new activities/workflows being implemented

Who are you?

• You hold a master’s degree with a minimum of 2-3 years of experience as a Bioanalytical Scientist with a proven track record in method validation and sample Testing in support of bioanalytical study phases
• You have a working Experience in regulatory environment (GLP/GCP)
• What about specific skills? You have experience with MSD and Elisa platforms and good knowledge in ADA
• You are fluent in English (French is a plus)

What can you expect?

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. Do you have any questions? You can contact Sophie Rolis: [email protected] or +32497/51.50.92

 

 

 

• Location: Braine l'Alleud
• Type: Contracting
• Job #19196

Change Leader

Contracting – Walloon Brabant

#laboratory #productrelease #procedures #changes #requirements

Our partner is currently looking for a Change Leader to join its team. This international company is well-known for its pharmaceuticals.

What are your responsibilities?

As a Change Leader, you will be in charge of the management of local specification to allow laboratory testing and Product Release, and you will ensure local specification are compliant to market and regulatory requirements. To be successful in your role, here are your tasks:

Operational:

• Manage local specifications changes (create / update) according to procedures in place and business needs.
• Coordinate the creation/review of the specification ensuring that the content is defined and developed with the involvement of the appropriate experts / stakeholders to grant compliance to regulations and related file.
• Checks the progress of the change with stakeholders and escalates any risks in the initially planned implementation schedule.
• Ensure communication between subject matter experts and stakeholders. Ensure all information is provided to the specification author to write local specification document in ECMS.
• Informs Lims partner when the specification is in status issued in ECMS and ensures to provide on time specific information allowing Lims configuration /process to operate with efficiency.
• Ensure planning and coordination in order to satisfy the client needs. Organize or participate actively to weekly/monthly planning meetings, propose solutions, demonstrate creativity and pro-activity in order to ensure adherence to plan and performance.
• Ensure local specification implementation is in alignment with global specification status.

 

Quality:

• Implement, follow-up and communicate on KPI.
• Ensure the continuous improvement of the activity.
• Ensure update or creation of related procedures and instructions.
• Ensure follow-up of corrective actions and preventive actions. Ensure audit readiness, participate to the preparation, the follow-up and the realization of audits.
• Ensure the follow-up of deviations and appropriate root cause analysis to address the right action plan.

HSE:

• Apply the company's Health and Safety policy
• Ensure a safe working environment to meet site safety objectives

Who are you?

You hold a master’s degree in a scientific domain. You have a proven experience in a GMP/laboratory environment. You have also an experience in data management (LIMS, SAP). You speak fluently French and English.

What can you expect?

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. Do you have any questions? You can contact Marie Rossenfosse, [email protected]

• Location: Braine L'alleud
• Type: Contracting
• Job #19132

Technicien(-ne) LIMS

Brabant Wallon – Contracting 
 

Notre partenaire est activement à la recherche d’un Technicien (-ne) LIMS pour completer son équipe. Notre partenaire est une multinationale connue pour la fabrication de produits pharmaceutiques.

Quelles sont vos responsabilités?

Au sein de l’équipe QC System du Département QC, le Technicien LIMS assure l’implémentation du système LIMS et tout ce qui s’y rapporte, dans le respect des règles cGMP’s, de la sécurité et des procédures en place.

Tâches principales

• Créer, modifier des spécifications dans le LIMS (y compris sampling plan, item code, …)
• Créer, modifier des analyses dans le LIMS
• Gérer l’aspect documentaire associé aux implémentations LIMS (Change request notamment)
• Participer et tester l’implémentation des fonctionnalités et rapports
• Participer à la gestion documentaire associée (déviation, CAPA, Change request).
• Apporter le support nécessaire à l’équipe en place
• Rapporter les déviations liées au LIMS (en utilisant le software de gestion des déviations en place), les problèmes techniques et exécuter les actions correctives 
• Proposer à son responsable toute mesure identifiée comme pouvant améliorer le travail dans le département du point de vue qualité, efficacité, sécurité, … comme exactitude et précision des méthodes, modifications de procédures, …
• Participer à l’identification des éventuels manquements du LIMS en matière de « Data Integrity » et proposer des solutions
• Participer à la formation des nouveaux membres du département et gérer les demandes d’accès.
• Participer à l’analyse et la mise en place de nouvelles fonctionnalités dans le cadre du LIMS 
• Interagir avec les équipes LIMS des autres sites et équipe globale.
• Participer à la résolution des problèmes liés au LIMS avec les équipes LIMS et les équipes sur le terrain.

Quel est votre profil ?

• Vous disposez d’un master en sciences, Bioingénieur ou assimilé (à titre d’information) (à titre d’information)
• Vous avez une bonne compréhension des flux (échantillons, données, résultats, certificats, …) en milieu QC
• Vous êyes dôté d’un esprit logique, synthétique, tout en aillant la capacité de vue d’ensemble
• Vous faites prevue de rigueur : suivi des règles GMP dans le respect des procédures et des méthodes analytiques.
• Vous pouvez gérer de la documentation GMP et suivi du data integrity
• Vous faites prevue de flexibilité et esprit critique
• Vous êtes organisé(e)
• Vous êtes autonome et proactive
• Vous parlez et écrivez correctement en anglais

Que pouvez-vous attendre?

Jefferson Wells vous propose un contrat à durée indéterminée en tant que consultant avec un package salarial attractif et vous donnera accès à des formations en matières techniques et soft skills. Nous serons votre partenaire de carrière pour chaque étape de votre chemin.

Cette offre vous intéresse ? Nous vous invitons à postuler. Si vous avez des questions, vous pouvez contacter Aurélie Montes Suarez : [email protected] ou +32(0)472/44.83.18

 

• Location: Braine-l'Alleud
• Type: Contracting
• Job #18296

Energy & Utilities Early Design Engineer

Contracting – Brabant Wallon 

Our partner is looking for a Energy & Utilities Early Design Engineer to reinforce its teams. Our partner is a well-known pharmaceutical industry.

Your responsibilities?

The Energy & Utilities Early Design Engineer is responsible for carrying out feasibility studies of Energy and utilities projects within Sites & Infrastructure Investment Strategy & Early Design Department and more particularly for the energy and utilities projects:

1. Consolidates the ideation of the energy and utilities projects: ​

   -​​Prepares and present scenarios to management for strategic decisions.
   -Delivers Feasibility and Early Design: user requirement brief, technical deliverables, budget, schedule, risks, alternative, prioritization
   -Transfers the feasibilities to the Delivery department in compliance with the governance
    

2. Assists the Sites & Infrastructure Partner, mainly in the field of energy and utilities:
   – Collecting user and site requirements
   – Completing the Project Ranking Forms
   – Establishing the project portfolio in the form of an investment plan
   – Contributes to the implementation of the Sites Master Plan
    
3. Propose technical solutions in order to:
   – 2030 environmental objectives: carbon neutral &reducing our water consumption by 20%.
   – Guarantee the necessary energy supplies
   – Optimize the Sites Utilities equipment’s and networks
    
4. Connect with his peers to have a deep understanding of the different Masterplans (Networks, Manufacturing, Laboratories…)

Your profile ? 

• Minimum 10 years in Infrastructure and Utilities projects like Project Leader or equivalent
• Minimum 2 years within chemical, pharmaceutical or biotech company with technical background (Energy, Utilities)
• Experience in capital and asset management
• Experience in Masterplan building
• Fluent in French and English.
• Expertise in cGMP, Green and HSE standards
• Expertise in chemical and pharmaceutical standards
• Good financial background, especially in depreciation management.
• Fundamentals in people management (incl change, decisions, conflicts, coaching, leading, etc…)
• Background and experience with risk management.
• Very good communication skill
• Good analytical impact on the business/legal rules.

Our offer?

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.

• Location: Braine L'alleud
• Type: Contracting
• Job #17117

Superviseur de chantier HVAC

Brabant Wallon – contracting 

#HVAC #Pharma

Notre partenaire est activement à la recherche d’un Superviseur de chantier HVAC pour supporter un projet de rénovation de plusieurs bureaux dans une mutltinationale pharmaceutique. Notre partenaire est un expert en HVAC, ses projets couvrent toutes les étapes des installations et le suivi de leur conformité.

Quelles sont vos responsabilités?

• S’assurer de la bonne avancée du projet sur le remplacement des HVAC
• Superviser les ouvriers
• Gestion du planning
• Gestion des documents adéquats au chantier (permis de travail, sécurité, suivi du chantier…)
• Collaborer avec l’ingénieur de projet pour revoir les plans, identifier et proposer des solutions aux éventuels problèmes
• Vous serez l’interface entre le client et notre partenaire

Qui êtes-vous?

• Vous avez un bachelier ou une experience en HVAC
• Une experience en gestion de chantier et d’ouvriers
• Vous êtes un bon communicateur et négociateur, vous avez une bonne capacité de planification et à résoudre des problèmes.

Que pouvez-vous attendre?

Jefferson Wells vous propose un contrat à durée indéterminée en tant que consultant avec un package salarial attractif et vous donnera accès à des formations en matières techniques et soft skills. Nous serons votre partenaire de carrière pour chaque étape de votre chemin.

Cette offre vous intéresse ? Nous vous invitons à postuler. Si vous avez des questions, vous pouvez contacter Sophie Rolis : [email protected] ou +32(0)497/51.50.92