Sterility Assurance

  • Location: rixensart
  • Type: Contracting
  • Job #18105

Sterility Assurance Officer

Brabant Wallon – contracting 

#Pharma #EM #Sterility

Our partner is looking for a Sterility Assurance Officer to join its team. This international company is well-known for its pharmaceuticals and vaccines. 

What are your responsibilities?

You will Provide support and expertise to the operations to ensure that the Manufacturing Performance Unit applies all Sterility Assurance processes. Here are your main tasks :

  • Approval of scientific and technical reports (test procedure, validation report, risk assessment, scientific report, …)
  • The re-qualification activities after the shut-down (PQ EM, among others)
  • Write procedures in relation with sterility assurance
  • Perform FMEA analysis on aseptic processes
  • Ensure the adequate treatment of all deviation linked with sterility assurance
  • Ensure and support the implementation of adequate training for aseptic gowning and practices (isolator and conventional processes) and sterility assurance, including shop floor mentoring as required

Who are you?

  • You hold a master’s degree in sciences or equivalent by experience
  • You have a first experience in Sterility Assurance
  • You have good knowledge of aseptic processes
  • You are flexible and are quality oriented

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

Safety coordinator

  • Location: rixensart
  • Type: Contracting
  • Job #18103

Safety Coordinator

Brabant Wallon – Contracting

#Pharma #EHS

Notre partenaire de l’industrie pharmaceutique connu pour ses vaccins est à la recherche d’un Safety coordinator pour intégrer son équipe.

Quelles sont vos responsabilités?

Le responsable EHS de la construction travaille au sein de l'équipe projet en étroite collaboration avec le directeur et le PM du projet qu’il soutient pour tous les domaines relatifs à la politique EHS applicable au chantier. Votre rôle :

  • Veiller au développement, à l’implémentation et au suivi du programme de management de la
    sécurité et de la santé qui définit la stratégie de notre partenaire pour ce qui est de la gestion EHS des activités de construction du projet,
  • Participer avec le management du projet à la definition de KPI’s et fait la publicité de ceux-ci via la publication mensuelle du tableau de bord EHS du projet,
  • Stimuler, encadrer et superviser l'équipe EHS du site au travers des réunions et des visites de terrain
  • Participer à l’évaluation de la compétence des entreprises lors du processus de préqualification,
  • Participer à l’évaluation de la compétence des personnes proposées pour des rôles de construction,
  • Veiller au suivi de la matrice des compétences du personnel actif sur le chantier,
  • Revoir, commenter et viser les plans de sécurité et de santé des différents contractants en veillant à ce que les risques généraux et spécifiques auxquels les travailleurs pourraient être exposés lors de leurs activités soient correctement identifiés et gérés
  • Participer à la revue des modes opératoires, des analyses des risques et auditer les permis de travail,
  • Initier des réunions de debriefings EHS à l’attention des acteurs du projet,
  • Procurer une aide active et partager son expérience lors des enquêtes d'incidents et d’accidents du travail,
  • Communiquer à l'équipe de construction en collaboration avec les EHS des contractants, les tendances de l'industrie, les modifications de la législation ou des modifications des exigences de notre partenaire à appliquer sur le site,
  • Veiller au bon fonctionnement et à la planification du programme d'audits et d'inspections EHS dans le cadre de l’évaluation du système de management EHS du projet,
  • Assurer que les tâches sont effectuées conformément aux modes opératoires
  • Veiller à la bonne coordination des activités de construction et assurer la liaison avec les différents responsables EHS
  • Participer et coanimer les séances de planification du travail sécuritaire,
  • Participer et coanimer les séances d'information quotidiennes avec les travailleurs sur la sécurité avant le démarrage des travaux,
  • Participer aux réunions de sécurité et être le driver des visites sécurité sur site,
  • Initier et coanimer les Toolbox meeting (Safety Awareness)
  • Evaluer le fonctionnement du système de management de la sécurité et de la santé,
  • Exploiter les résultats des audits sur la sécurité et la santé pour mettre en place des solutions d’amélioration

Qui êtes-vous?

  • Vous bénéficiez d’une experience confirmée dans le domaine du management de la sécurité et de la santé de gros projets de construction
  • Vous avez une bonne connaissance de la legislation belge en matière de Bien-Être
  • Vous aimez travailler en équipe et êtes un bon communicateur

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 professionnel.

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

Validation Engineer

  • Location: RIXENSART
  • Type: Contracting
  • Job #18099

Validation Engineer

Brabant Wallon – contracting 

#Pharma #Validation

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

What are your responsibilities?

You will manage equipment validation and requalification. Here are your main responsibilities:

  • To perform risk assessments
  • To write and/or review validation protocols
  • To schedule and design validation activities, priorities, logistics, supplier interventions
  • To perform or manage validation and flows of documentation
  • To report project progress, risk and mitigation in team meeting

Who are you?

  • You hold a master’s degree in sciences or equivalent by experience
  • You have 3 years of experience in validation within the pharmaceutical industry
  • You have good knowledge in qualification/validation process
  • You are flexible and have good organization skills

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: sophie.[email protected] or +32497/51.50.92

Maintenance Scheduler

  • Location: RIXENSART
  • Type: Contracting
  • Job #18045

Maintenance Scheduler

Brabant Wallon – contracting 

#Pharma #Maintenance

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

What are your responsibilities?

As Coordinator Planning Shutdown and Maintenance Scheduler you will:

  • Ensure in the short and long term the coordination of the interventions and interactions between maintenance, the validation, engineering, the shared Services, laboratories central C&M and the production
  • Lead meetings of preparation and execution of the shutdown with the all the stakeholders
  • Identify and discuss the items blocking with the teams
  • Guaranty by your actions the good execution of the obligatory interventions in respect of the estimated timing by guaranteeing the absence of impact and the optimization of production capacities
  • Be responsible for the construction and the review of planning for intervention to short, means and long run
  • Be in charge of the initial review of the orders of work entering, including the identification of the range and the analysis of the degree of necessary planning
  • Carry out examinations on the floor to identify and document the necessary ones, as well as the possible hazards related to the realization of work
  • Coordinate and communicate clearly on the critical stages of the process with the technical managers, the persons in charge of production, quality responsible and the technicians.
  • Ensure internal management and you will be the single interface (LSPOC) of the unit with the shared engineering services (Automation support/Metrology laboratory)
  • Gather and provides SAP reports concerning the management of the completion of the work

Who are you?

  • You hold a Scientific master’s degree (Engineer or equivalent)
  • You have 2 years of experience in a similar role in a Pharmaceutical environment
  • You have good knowledge of planning ‘processes
  • You are pragmatic and have good communication skills

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

Quality Assurance (QA) Validation

  • Location: rixensart
  • Type: Contracting
  • Job #17893

Quality Assurance (QA) Validation Officer

Brabant Wallon – contracting 

#QA #GMP #Validation #Pharma

Our partner is looking for a QA Validation Officer to join its team. This international company is well-known for its pharmaceuticals and vaccines. 

What are your responsibilities?

The Quality Assurance Validation officer will ensure the QA oversight of the continuous validation activities and of the technical services activities for one or several vaccine bulk production units.
Here are your main responsibilities:

  • To take part in the establishment, the implementation, the follow-up and the maintenance of the continuous validation plan (CVP),
  • To assess the validation state of equipment’s through writing periodic review report and/or risk assessments
  • To write and implement some validation documentation (VP, VSR, Risk Assessment, Gap Analysis),
  • To review and approve specific qualification and validation documentation (IQ, OQ, PQ, PV),
  • To ensure the correct application of the validation quality systems on the field and to define improvement plan as required,
  • To support the production & technical services teams in the implementation of the validation activities,
  • To ensure the periodic oversight of technical services activities,
  • To review the modification proposed by the technical teams
  • To ensure adequate level of quality on the floor through gembas and quality coaching of technical teams.

Who are you?

  • You hold a master’s degree (biotechnology, agronomy, chemistry or pharmacy)
  • You have at least 2 years of experience in a similar position within the pharmaceutical industry (good knowledge of GMP)
  • You are a problem solver and solution oriented
  • You are fluent (written and spoken) in English and French

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

Supply Planner

  • Location: RIXENSART
  • Type: Contracting
  • Job #17830

Supply Planner

Brabant Wallon – contracting 

#SupplyChain #SAP #APO

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

What are your responsibilities?

  • Delivering production plans for a product/franchise on a monthly basis at SKU level (in APO). Manage all planning master data & parameters to allow automatic use of system (APO optimizer).
  • Provide visibility of End to End status across a product/franchise, manage risks & opportunities.
  • Ensures Bulk and Fill plans can fulfill packaging and Customer Demand.
  • Prepare scenarios in case supply issue occur and/or manage all constraints (Regulatory Affairs, life-cycle management, Quality)
  • Be the contact person to other stakeholders in the organization (Regulatory, Quality, Manufacturing Strategy, Technical life cycle Management, central planning, Global Product Leads..)
  • Manage product inventory (vs target) and monitor product performance (master data, inventory, leadtime)
  • Reflect customer demand in APO

Who are you?

  • You hold a bachelor’s degree and a Supply Chain certification is a plus.
  • You have 3 years of planning experience in a complex organization
  • You have good knowledge of SAP/APO
  • You are a team player and autonomous
  • 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] or +32497/51.50.92

Project Engineer

  • Location: RIXENSART
  • Type: Contracting
  • Job #17483

Project Engineer

Walloon Brabant – Contracting

#project #userrequirements #stakeholders #customers #qualification #training #pharma #GMP

Our client is looking for a Project Engineer to reinforce its teams. Our client is a well-known pharmaceutical industry.

What are your responsibilities?

As a Project Engineer, you will:

  • Ensure basic design of technical projects within MPU
  • Collect user requirements
  • Projects budgets first assessment
  • Prepare change with stakeholders and customers (Leadership team, Production Team, Operational maintenance team, QA Team, P&P – Product & Process – Team…)
  • Work with suppliers in collaboration with procurement department
  • Ensure works coordination during installation phase
  • Ensure start up and qualification
  • Ensure operator training and hand over for maintenance or production team

Who are you?

You hold a university degree in a technical field. You have a relevant experience in project and people management in a technical service. You have a deep knowledge of quality and regulatory pharmaceuticals requirements (GMP, cGMP, etc.). You also have a good knowledge of V-Cycle (validation) in the pharmaceutical industry. You have a good mastery of MS Project. 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 Defruit, [email protected]

QA Validation

  • Location: RIXENSART
  • Type: Contracting
  • Job #17430

QA Validation

Brabant Walloon – contracting

Our partner is looking for a QA Validation Consultant to ensures QA oversight and support quality tasks linked to projects led by the Manufacturing Science and Technology (MSAT) department. This international company is well-known for its pharmaceuticals.

Your responsibilities?

  • Challenge, review and approve documentation associated with MSAT projects in accordance with the GSK Vaccines standards and procedures.
  • Write some validation documents according to standards and procedures.
  • Support the QA Operations regarding validation topics
  • Understand how production equipment’s work and assess their impact on product and patient safety
  • Use a risk-based approach in order to solve problems and prioritize tasks
  • Make sure that a quality and compliance mindset governs all validation activities
  • Develop and continuously improve his/her expertise about validation activities

Your profile?

  • Experience in QA validation within the pharmaceutical industry
  • Good knowledge of cGMP
  • Knowledge of digitalization processes
  • Knowledge of different regulations and standards related to validation activities
  • Fluent in English
  • Autonomy

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. Do you have any questions? You can contact Béatrice Stroobants, [email protected] 

 

Specialist GDP

  • Location: RIXENSART
  • Type: Contracting
  • Job #17229

Specialist Good Distribution Practices

Walloon Brabant – Contracting

#QA #compliance #GDP #GMP #documentation #clinical #coldchain #pharma

Our partner is looking for a Specialist GDP to reinforce its teams. Our partner is a well-known pharmaceutical industry.

What are your responsibilities?

As a Specialist GDP, your main tasks will be:

1/ Review and Approval of GDP documentation used in the frame of IMP Clinical Supplies :

  • Review of Supply Flow aligned with Logistical Strategy and Qualified status of Logistic Supply Partner,
  • Review of feasibility assessment for the transfer between Commercial Sites, R&D Sites and CMO or between Clinical Sites to ensure product quality is kept at receipt as well as the Third Parties compliance.

2/ Writing and/or Review of Cold Chain documentation:

  • Documentation provided to CMO / CRO to confirm storage condition and allocate Cold Chain budget for their activities;
  • Confirmation of Cold Chain budget remaining for Clinical Sites’ activity at Release stage
  • Assessment of temperature excursion during storage and/or distribution of IMPs

Who are you?

You hold a degree in sciences. You have a relevant experience in quality assurance in the pharmaceutical industry. You have a good knowledge of cGMP and GDP. You speak fluently French and English. You are a good communicator, autonomous, team player, rigorous and structured.

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 Defruit, [email protected]  

Doc&Training Project Manager

  • Location: RIXENSART
  • Type: Contracting
  • Job #17027

Doc & Training Project Manager

Walloon Brabant – Contracting

#QA #PM #Pharma

Our partner is looking for a Doc &Training Project Manager. You’ve had a first experience within the pharmaceutical industry? Our partner is well known for its pharmaceutical and vaccines

What are your responsibilities?

You will work in close contacts with the key users (global and business representatives) to maintains the overall view on all actions and initiatives related to the migration of Documentation applications to the new corporate platform. Here are your mains responsibilities:

  • Maintain a detailed project tracker for all initiatives linked to the migration of all different applications to the platform
  • Manage multiple workstreams in parallel
  • Manage all the stakeholders effectively both on global and business side
  • Make sure that all changes in timing, scope and costs are duly reported and risks are promptly raised if needed
  • Support the creation of strategic/operational material to drive the project implementation effectively (training, communication, governance, data analysis etc.)
  • Able to identify and mitigate project risks
  • Work as part of the team and act as a reference point when a global view is needed
  • Act as coach on project management methodology and best practice sharing to support the whole team when needed

Who are you?

  • You hold a bachelor’s degree
  • You have at least 5 years of similar experience within the pharmaceutical industry
  • You have good knowledge in risk management and project migration
  • You are risks oriented, proactive, and pragmatic
  • You are fluent English (both written and spoken), French is a strong asset

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