Our partner is looking for a Construction Manager to join its team. This international company is well-known for its pharmaceuticals and vaccines.
Your responsibilities?
To have overall responsibility for monitoring and organizing the construction and demolition activities associated with the Project.
To ensure that a comprehensive Construction and Demolition Plan is prepared and updated, which co-ordinates all Project construction and demolition activities.
To provide the management resource, as appropriate, throughout the construction and demolition phases to ensure co-ordination of activities and achievement of agreed milestones.
To ensure designers, contractors and other team members are EHS competent and appropriately prequalified • To ensure that the Manager of the Construction (contractors) delivers the project safely in conformance with the local regulations and in compliance with the company requirements
To agree the responsibilities and accountabilities for project construction EHS with the host site EHS Manager
To encourage and support an EHS culture that supports the values of the company
To write the initial Construction Safety Plan (CSP) for briefing the Manager of Construction (contractors)
To ensure all workers receive a host site and project specific construction induction
To ensure that the CSP is regularly reviewed and updated by the Manager of Construction
To implement a process of EHS performance assurance through a programme of audits, observations and interactions
To ensure that the Manager of the Construction (contractors) implements a proactive EHS programme encouraging recognition of the workforce and feedback / engagement with the workforce
Your profile?
Degree in Engineering or Sciences
Experience in a similar function
BA5 certificate
Pharmaceutical experience is an asset
PM experience
PM certification is an asset
Rigor in execution, results driven; Demonstrated strength in problem solving
Analytical skills and demonstrated ability to influence
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.
Manage ordering process and coordinate transport activities related to the commercial products including transport planning, shipping documentation and customs declaration.
Act as a unique point of contact for a high-quality customer experience for the client and ultimately the patients
Build a strong relationship with local Supply Chain managers,
Be active and manage Markets queries by taking ownership/responsibility and liaising with the different internal departments if necessary,
Be proactive in identifying their needs and potential problems to continuously improve collaboration and provide the best possible service.
Collaborate with applicable stakeholders internally and externally: planning, commercial, finance, QA, master data, transport carriers, warehouse operators…
Are you the candidate we're looking for?
You are fluent in French & in English
You have 3 years experience in Supply Chain (logistic experience is a big advantage) within the pharmaceutical industry
You have a good knowledge of SAP
You have an experience in GMP
What can we offer you?
At Jefferson Wells, we offer you an indefinite contract, with a competitive salary commensurate with your experience (company car, meal vouchers, etc.).
Do you want to know the rest of the recruitment process?
If this sounds like you and you're keen to find out more, I urge you to apply!
Then, in the next few days, a recruiter will get in touch with you to go through your CV and find out what motivates you. I promise, we're friendly! ☺
We can't wait to meet you, so don't wait any longer!
Superviseur Biochimie #Superviseur #biologie #biology #biochimie #biochemistry #chimie #chemistry #pharma Pour l’un de nos partenaires, une entreprise pharmaceutique située dans le Brabant Wallon, nous recherchons un Superviseur Biochimie. Alors, si vous êtes orienté biochimie et que vous êtes intéressé par le people management, la suite va vous plaire ! Quelles sont vos responsabilités ? En tant que Superviseur Biochimie, votre mission sera de :
Diriger et planifier des analyses QC de haut niveau.
Résoudre des troubleshootings techniques et mener des investigations approfondies.
Estimer la faisabilité des analyses demandées par les clients.
Évaluer les besoins en réactifs et en personnel pour assurer un fonctionnement optimal.
Réaliser des évaluations périodiques de votre équipe, identifiant les besoins en formation.
Planifier et approuver les demandes de congé.
Favoriser la motivation, informer, soutenir et coacher les membres de votre équipe.
Qui êtes-vous ? Nous recherchons un professionnel passionné avec :
Une formation de niveau master en chimie, avec une orientation spécifique en biochimie ou expérience équivalente.
Une expérience professionnelle significative en laboratoire.
Une expertise approfondie en biochimie analytique et instrumentale (HPLC, UPLC, CE).
Une maitrise d’Empower et une connaissance souhaitée en 32Karat.
Une expérience en gestion d'équipe serait un atout.
Une maitrise du français et un bon niveau d’anglais scientifique.
Que pouvez-vous espérer ? Notre client vous offre un package salarial attractif complété d’avantages extra-légaux et l’opportunité d’évoluer au sein d’un groupe dynamique et innovant. Si vous êtes intéressé, n’hésitez pas à me contacter, via [email protected] Nous n’attendons plus que votre candidature pour discuter de votre projet professionnel.
Superviseur Biologie Moléculaire et Cellulaire #Superviseur #biologie #biology #moléculaire #cellulaire #pharma Pour l’un de nos partenaires, une entreprise pharmaceutique située dans le Brabant Wallon, nous recherchons un Superviseur Biologie moléculaire et cellulaire. Alors, si vous êtes orienté biologie et que vous êtes intéressé par le people management, la suite va vous plaire ! Quelles sont vos responsabilités ? En tant que Superviseur Biologie Moléculaire et Cellulaire, votre mission sera de :
Diriger et planifier des analyses QC de haut niveau.
Résoudre des troubleshootings techniques et mener des investigations approfondies.
Estimer la faisabilité des analyses demandées par les clients.
Évaluer les besoins en réactifs et en personnel pour assurer un fonctionnement optimal.
Réaliser des évaluations périodiques de votre équipe, identifiant les besoins en formation.
Planifier et approuver les demandes de congé.
Favoriser la motivation, informer, soutenir et coacher les membres de votre équipe.
Qui êtes-vous ? Nous recherchons un professionnel passionné avec :
Une formation de niveau master en biologie, avec une orientation spécifique en biologie cellulaire et/ou moléculaire ou expérience équivalente.
Une expérience professionnelle significative en laboratoire.
Une expertise approfondie en biologie moléculaire/cellulaire et biochimie.
Une expérience en gestion d'équipe serait un atout.
Une maitrise du français et un bon niveau d’anglais scientifique.
Que pouvez-vous espérer ? Notre client vous offre un package salarial attractif complété d’avantages extra-légaux et l’opportunité d’évoluer au sein d’un groupe dynamique et innovant. Si vous êtes intéressé, n’hésitez pas à me contacter, via [email protected] Nous n’attendons plus que votre candidature pour discuter de votre projet professionnel.
Review/Approve the validation documentation regarding the GMP requirements and the Vaccines procedures
Ensure that production practices are aligned with validation conclusion
Attend all project meetings as QA validation representative
Ensure timely escalation to Management of critical issues during validation
Contribute to the deviation process providing QA oversight and approving deviation for deviations related to validation activities and/or impact of manufacturing deviations to validation activities
Pro-actively identify potential quality and compliance risks and manage these risks through the risk register and quality plan process
Work in autonomy with supervision/coaching
To define the validation strategies through the change control process
To write and implement some validation documentation (Validation Plan, Validation Summary Report, Risk Assessment, Gap Analysis , Periodic review ….)
Let's talk about you !
You hold a Master’s Biotechnology, Agronomy, Chemistry or Pharmacy
You have experience with SAP
You have knowledge of GMP’s standards
You have good communication skills to be the only point of contact between other stakeholders
You are Fluent in French and able to speak and understand English
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.
You’re interested in this job? We kindly invite you to apply.
You’re interested in this job? We kindly invite you to apply. Do you have any questions? You can contact Aurélie Montes Suarez: [email protected] or +32472/44.83.18
Our partner is looking for an Supply Network Planner – DS (Drug Substance) to join its teams. This international company is well known for its pharmaceutical products.
Your responsibilities?
Production MPS Planning
To build and deliver a feasible MPS plan for one or several production nodes on the MPS time horizon (18M+) and PrO and PO hand over to production partners
To use the company adopted Advanced planning tool – OMP+ and SAP – to build monthly/weekly MPS where applicable – based upon Anaplan input developed by E2E products planners
Ensure that production plans are in line with customer requirements, stock policies and E2E S&OP products planners plans
In charge the Distribution Replenishment plan (DRP) for managed products. Collaborate closely with Global distribution & logistics for managing day-to-day operations.
Run the capacity reconciliation assessment, identify gaps, find solutions with partners, vendor teams or site local planners and escalate to S&OP level if required. Set in place ad hoc capacity review (S&OP) with production sites (CMO and internal)
To manage all transactional data into the system for his/her dedicated assets based plan calculated at tactical level
Control execution of the plan over the frozen and MPS horizon
Ensure that production plans are in line with previous production step availability
Manage potential changes of plans in the frozen horizon
To manage the supply risk on the short and mid-term horizon in collaboration with markets, TPA PVU Supply, Vendors, QA and E2E product planners;
To create STO once stock is available and communicate with logistics
To plan & coordinate with production and schedulers all restamps, reworks, validations, maintenance stops and availability of batches under deviations.
To manage change controls linked to planning activities
To consolidate Inventory requirements (Projection, Provision & Destruction) and be main point of contact for different functions
Production nodes (CMO and internal sites) Supply Performances Management :
In charge of weekly supply performances monitoring and analysis on defined KPI’s definition (OTIF, ATP,..). Responsible to facilitate the supply performances discussion within the Vendor team and with partners.
In charge Root cause analysis (Measure, Analyze, Improve and Control), primary performances lead in the vendor teams.
Responsible for leading performances management into the Tier departmental structure and on-site if any
Production nodes (CMO) Capacity planning: development of capacity/capabilities views for each production nodes, support to elaboration of future mutual supply agreement with CMO. Active participation to SIOP cycle (pre-SRM, SRM, IR), participation to capacity extension projects and initiatives with production nodes rep with the vendor team. Alignment on capacity assumptions SAP/OMP to E2E Product planner tactical scenario planning and decision
Escalation Resolution: lead escalated supply issues resolution on production nodes with support of the vendor team and the supply network lead. Is accountable to update stakeholders on supply impact, resolution, figures and will support issue resolution acceleration within vendor team and the production sites representatives (hot topics, hypercare,…)
Planning integration : integration of input to supply plans, scenario planning, feeding decision making, support supply issues resolution
Process & Systems enhancement: drive and provide inputs to supply center of excellent (SC CoE), global planning and global distribution to ensure right process and system governance execution and propose improvement initiatives when needed (planning, order fulfillment, forecasting, performances management, etc…)
Partnering: accountable for creating relationship and trusted collaboration channel with supply chain representative of production sites, improve and sustain ways-of-working according to guidance and Network management playbook. Participate actively to vendor teams meeting and OMR.
NPL & LCM : Master Data Readiness, Artwork readiness (labelling implementation), PO – MPS alignment, Readiness of DS batches for next step, Readiness of DP batches for next step, Readiness of Devices for next step, Readiness of FG batches for initial mfg + packaging, Production sequence agreement, Confirmation of initial supply (volumes and delivery dates), Samples agreements – Launch (FG/DP/DS)
Digitalization & Innovation : support innovation & digitalization initiative in partnership with GSC teams (SC CoE), CMO network Steering co up to project execution start
Manage Network Change: Input to Business Case, Vendor supply agreement creation, Capacity model definition, Critical parts definition, CMO operating strategy alignment, Align CMO segment, Translate CMO segment requirements into operating choices
Risk Management & Escalation flow : accountable for ensuring governance of risk management governance for CDMO network of what is beyond operational short term risks (provide inputs, assessments, mitigation) for tier-1 up to key tier-2 or tier 3 suppliers.
Your profile?
Bachelor's or Master's Degree
Certification (Describe): APICS fundamentals
Language skills : Fluent in French and English
Background in pharma Operations and/or Planning experience. Technical skills in associated manufacturing process is a plus
Performances Driven
Systems skills in SAP/OMP (or fast learner)
Experience or willingness to the manufacturing operational environment
Stakeholder management, skills to influence
Able to manage Details and complexity
Clear in oral and written communication (English)
Analytical mindset, KPI and Result Driven
Demonstrated Planning and constraint management capabilities
Ability to learn fast within a complex environment
Rigorous person, able to go from High view to very detailed view
Ability to influence others at all level of the organization
Capable of challenging ideas and providing Feedback in a constructive way
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.
You’re interested in this job? We kindly invite you to apply. You can contact Noémie Sheta : [email protected]
Our partner is looking for an Global Distribution Specialist to join its teams. This international company is well known for its pharmaceutical products.
Your responsibilities?
Follow up on low cover items and proactively co-ordinate with Planning to ensure timely delivery of products
Act as intermediary between the company Markets and supplying sites
Monitor daily open stock transfer orders for the company Markets
Analyze latest market/country information to understand mid and long-term supply requirements
Create deliveries (upon shipping schedule in place) and daily follow-up on shipments
Organization of transports and preparation of necessary documentation related to shipments, organized in accordance with the specific instructions of each customer, packaging site and inter-company customer including hazardous goods requirements when applicable, including for TPA deliveries
Choose optimal mode of transport based on customer’s request and list of validated vendors
Control transportation costs against agreed rate cards and spot quotations when required
Co-operation with external/internal WHs for the control and monitoring of receiving, storage and order preparation operations, including the management of Idocs related to these activities.
Provide local Supply Chain managers with regular updates on their coming replenishments
Address complaints to appropriate departments in charge and follow up if necessary
Handle returns from the company Markets to supplying sites
Execute contractual reconciliations or price transfers
Issue Credit/Debit Notes where applicable
Maintain client working instructions in Global Customer Service database & commercial client files in SAP for the company Markets
Contribute in launch preparation for individual portfolios
Participation in operational meetings within GL
Calculation and monitoring of KPIs followed during Tier meetings
Maintain proper and accurate Pre-Shipment and Post-shipment Administration
Management and follow-up of each customer's specific logistic instructions via customer file
Knowledge of relevant SOPs and supporting systems (eg. ColdStream, Trackwise, Qlik)
Your profile?
Bachelor's Degree
3-5 years’ experience in area of: Customer Service, Logistics, Warehouse operations, Transportation
Language skills : Fluent in French and English
Customer Service oriented
Functional knowledge of Supply Chain processes
Knowledge in transportation and Warehousing, preferably in the Pharmaceutical industry
Knowledge in Good Distribution Practice, Cold Chain Distribution, Incoterms and understanding of customs clearance processes.
Experience with any ERP, Office (strong focus on Excel), SAP is a strong advantage
Stress resistant, analytical, flexible, able to work independently, strong team spirit, excellent verbal and written communication skills and customer focused
Exceptional organizational skills
Excellent attention to detail
Experience within the context of an international organization
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.
You’re interested in this job? We kindly invite you to apply. You can contact Noémie Sheta : [email protected]
Notre partenaire, une entreprise internationale connue pour le développement et la production de médicaments, recherche un Analyste QC pour renforcer ses équipes.
Vos responsabilités ?
Vous effectuez le contrôle des produits pharmaceutiques finis en vrac ou conditionnés conformément aux instructions de travail et procédures préétablies.
Vous participez à la tâche de planification, et donc, assurez avec l’aide du superviseur le suivi du planning de manière à respecter les délais impartis sur chacun des lots à analyser.
Vous veillez aux stocks de consommables et recommandez/signalez en temps et en heure le matériel nécessaire au fonctionnement du laboratoire pour éviter tout arrêt d’activité.
Vous participez à la mise en place et à veillez au respect du programme de housekeeping/5S du laboratoire.
Vous participez activement dans les investigations à mener lors de résultats analytiques non-conformes ou aberrants.
Vous proposez au Responsable du laboratoire toute mesure (choix d’appareil, de réactifs, de méthodes, organisation du travail, modification de procédures, besoins en training, etc.) permettant de réduire les délais et coûts d’une part, et d’améliorer la précision et l’exactitude des essais d’autre part.
Vous participez au programme de maintenance et/ou de qualification de l’appareillage du laboratoire.
Votre profil?
Graduat, Bachelier, Master ou équivalent dans les domaines de la Chimie, Biochimie, Biologie.
Une expérience préalable dans un environnement soumis aux normes GMP, BPF, ICH est un requis.
Une expérience préalable dans un département Contrôle Qualité est requise (minimum 2 ans d’expérience).
Le requis pour cette fonction est une connaissance approfondie des techniques d’analyse biochimiques telles que : le Bioassay (comprenant notamment : passage cellulaire, gestion des master cell bank/ working cell bank, analyse de type « cell based assay »), L’ELISA, la qPCR, etc…
Une maîtrise de la manipulation sous conditions aseptiques
La connaissance de Trackwise ou software équivalent pour la gestion des déviations et LIMS ou équivalent pour la gestion des échantillons est un atout.
Une bonne connaissance de l’anglais technique lu et écrit est un atout
Vous aimez travailler en équipe avec un grand sens de l’autonomie et du respect.
Vous êtes focalisé sur l’amélioration continue avec un solide état d’esprit orienté qualité et « green »
Le département Contrôle Qualité nécessitant parfois des délais très courts, vous avez la capacité de bien gérer le stress si nécessaire et d’être flexible
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.
Our partner is looking for a Formulation Scientist to join its team. This international company is well-known for its pharmaceuticals.
Your responsibilities?
Supporting the development of formulation of monoclonal antibodies through the application of manufacturing (buffer exchange) and analytical techniques (H/UPLC, cIEF, UV spectroscopy, DLS, CGE, etc.).
Preparing formulations of antibody for stability studies and collecting experimental data following established analytical methods.
Writing accurate and precise experiment records, for all activities following Good Scientific Practices.
Helping to generate study protocols and reports to justify the selection of preferred NBE formulations.
Your profile?
Biotechnology, Biology or Analytical (bio)chemistry degrees.
Min. 2 years of industrial experience, experience with analytical techniques and/or formulation, ideally with proteins/antibodies derived molecules.
Practical laboratory skills with HPLC/UPLC (especially size exclusion), cIEF, UV/Vis spectroscopy, DLS, CGE, rheology, etc.
A working knowledge and practical laboratory experience of antibodies and their formulation, including freeze-drying.
Experience or interest in protein structural modelling is a plus
Experience in writing accurate and precise experiment records
Experience with data analysis and interpretation, protocols and summary report writing would be a plus.
Technical English is mandatory.
Familiar with a creative, flexible, fast pace and stimulating environment in a multidisciplinary team.
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.
Global Quality Lead Support Brabant Wallon – contracting
Our partner is looking for a Global Quality Lead Support to strengthen its team. This international company is well-known for its research, development, and marketing of pharmaceutical and vaccines.
What are your responsibilities?
This position provides support to a Global Quality Lead relative to Quality Assurance activities associated with the lifecycle management for a product transitioning from Development to Commercial by:
Product Change Control Committee preparation and change controls follow-up, quality review for change proposals related to the product life cycle management.
Maintenance and lifecycle management of QA product flows
Audits and Inspection anticipation and readiness
Review of Annual Stability Plan
SOPs and other control documents writing, review and approval as needed
Building and maintenance of Product QA knowledge (i.e., Product(s) SharePoint(s))
Risk management and mitigation if applicable (e.g., follow-up on risk actions with QA stakeholders)
Review and approval of CMC sections linked to regulatory original submissions, renewals or variations during any moment of the lifecycle management of the assigned products as needed
Preparation and execution of Product launches from QA perspective (support in QA-RA assessment, support in QA activities, complaint readiness, shipping validation) as needed
Who are you ?
You already worked in GMP environment for 5 years
You are experienced in operating across cultures and in a multi-cultural environment
You have experience in GMP audits and inspections would be an advantage
You are Fluent in French and your English is not bad
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.
