GMP Compliance

  • Location: Wavre
  • Type: Contracting
  • Job #20811

GMP Compliance   

Brabant Wallon – contracting 

Our partner is looking for a GMP Compliance to join its team. This international company is well-known for its pharmaceuticals products. 

What are your responsibilities?

The purpose of the role is to support the operation QA team to assure and maintain the organization of the activities linked to the quality oversight of the manufacturing activities by:
 

  • Supporting the compliance authority for change controls linked to HPV restart
  • Following up of the planification and execution of SOP reviews linked to CAPA implementation
  • Assuring quality oversight for the planification of HPV production (day to day questions…)
  • Writer role for sterility assurance topics: Risk assessment environmental monitoring (EM), review PQ EM , review EM SOPs
  • Identifying, developing and Implementing improvements to the quality oversight processes for HPV restart

Who are you?

  • You hold a University degree: master degree in Sciences or Engineering
  • You have at least 5 years experience in the Pharmaceutical/Biotech industry with significant experience of GMP
  • You are open minded, determined, curious, well organized, rigorous and sociable
  • You speak 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. 

QC Analyst

  • Location: Braine l'Alleud
  • Type: Contracting
  • Job #20805

QC Analyst

Brabant Wallon – contracting 

#Laboratory #HPLC #QC

Our partner is looking for a QC Analyst to join its team. This international company is well-known for its pharmaceuticals products. 

What are your responsibilities?

The primary goal of the mission is to contribute to the release and stability testing according to the agreed quality standards and timelines. You will work in a team environment, collaborating with various scientists and technicians in cross-functional project teams by:

  • Performing daily laboratory activities related to release and stability testing
  • Analysing results
  • Double check for verifying data
  • Working with other analysts in organizing the release and stability analyses of the laboratory
  • Following up deviations, incidents and results validation within a LIMS system
     

Who are you?

  • You hold a Bachelor degree in biochemistry or analytical chemistry
  • You have at least 5 years of relevant experience in the pharmaceutical industry
  • You have experience in the following analytical techniques: chromatography (HPLC/UPLC) applied to proteins and capillary electrophoresis
  • You have good knowledge of GMP standards in QC laboratory
  • You are able to read technical documents 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 Aurélie Montes Suarez: [email protected] or +32472/44.83.18

Validation Expert Support

  • Location: Wavre
  • Type: Contracting
  • Job #20791

Validation Expert Support

Brabant Wallon – contracting 

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

What are your responsibilities?

  • Perform risk assessments
  • Write and/or review validation protocols
  • Schedule and design validation activities, priorities, logistics, supplier interventions
  • Perform or manage validation and flows of documentation
  • Report project progress, risk and mitigation in team meeting

Who are you?

  • You hold a Bachelor’s degree in Life Sciences
  • You have 3 years experience in Validation
  • You have a previous experience in the pharmaceutical industry
  • You speak French and English
  • You are able to manage complexity
  • You are solution oriented and teamplayer

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 Aurélie Montes Suarez: [email protected] or +32472/44.83.18

QA Sterility

  • Location: Wavre
  • Type: Contracting
  • Job #20789

QA Sterility

Brabant Wallon – contracting 

Our partner is looking for a QA Sterility 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 Sterility Assurance processes by:
 

  • Managing relationship with aseptic operations in the context of the tasks described
  • Identifying potential quality and compliance risks and help to manage these risks through the existing quality systems
  • Performing gap analysis, system effecttiveness reviews and other management reviews, as required
  • Guaranting the maintenance of the cGMPs in the area of responsibility (SOP, documentation, audits, training, method validation)
  • Ensureing and supporting the implementation of adequate training and practices related to sterility assurance, including shop floor mentoring as required
  • Driving and executing continuous improvement project or remediation plan related to sterility assurance, including change control management, SOP’s review

Who are you?

  • You hold a PhD or Master in Sciences (Microbiology, Engineering, Bio- engineering, , Pharmacy ……) or equivalent by experience
  • You have relevant experience in sterility assurance
  • You have a previous experience in QA in the pharmaceutical industry
  • You speak French and English
  • You have strong communication skills with all levels
  • You are solution 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 Aurélie Montes Suarez: [email protected] or +32472/44.83.18

Incoming material Validation Support

  • Location: Wavre
  • Type: Contracting
  • Job #20747

Incoming Material Validation Support

Walloon Brabant – Contracting

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

What are your responsibilities?

  • Manage the qualification of incoming materials and suppliers 
  • Manage a collaboration with the suppliers in order to ensure quality of suppliers, service providers and Incoming materials and to ensure that the company quality requirements and expectations are taken into consideration
  • Manage change received from the supplier
  • Understand and deploy regulatory constraints (GMP, ISO …), as well as internal procedures, related to management of incoming materials
  • Manage deviation and CAPA if needed
  • Give support to the QA validation team, if needed
  • Perform and follow material qualifications in partnership with the other departments
  • Communicate suppliers/quality issues to stakeholders through appropriated escalation processes
  • Understand and manage current regulatory requirements, as well as internal, environment related to incoming materials 
  • Be able to support the team by writing deviation and CAPA
  • Support team members on specific activities.

 Who are you?

  • University Degree in a relevant scientific (biology, chemistry, pharmacist …), quality or technical discipline
  • Relevant experience in the pharmaceutical industry and understanding of cGMP regulatory requirements and standards
  • Knowledge of production processes
  • Knowledge of regulatory and quality system requirements
  • An Experience in QA validation is welcome
  • Good verbal and written communications skills in French and English 
  • Ability to function efficiently in a matrix organization in order to ensure effective communication of issues to all impacted sites / functions

Our offer?

We offer you an open-ended contract as well as an attractive salary package. You will also take advantage of the opportunity to develop yourself personally and professionally through internal training.

Interested? Do not wait any longer!

HVAC Engineer

  • Location: Wavre
  • Type: Contracting
  • Job #20743

HVAC Engineer

Brabant Wallon – Contracting

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

What are your responsibilities?

In coordination with Engineering Office and Project Manager, you will ensure correct design, construction, commissioning, and qualification in full compliance with internal requirements and authorities' requirement of HVAC packages (networks, installation and pieces of equipment, UDF / LAF / cold rooms / incubator / etc, regulation, BMS supervision);

Related to these packages, it includes:

  • Being the company representative for all HVAC-related activities and installations
  • Supporting the E.O in management of activities related to this package
  • Ensuring alignment between E.O and the company Specification and Guidance
  • Reviewing design and technical documentation
  • Following-up construction & all testing activities falling under the package ‘scope
  • Ensure systems start-up and punch list solving
  • Provide projects support in terms of technical expertise, contractors’ management and troubleshooting capabilities.
  • Facilitating handover process towards the end user

Who are you?

  • You are Industrial or Civil Engineer with min. 8 years of experience in a similar role in domain of cGMP HVAC within the pharmaceutical industry
  • You hold the BA4 BT electrical certification
  • You are autonomous, good communicator and team player.
  • You are fluent 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.

Engineering Specialist

  • Location: Braine L'Alleud
  • Type: Contracting
  • Job #20719

Project Engineering Leader

Brabant Wallon – contracting 

Our partner is looking for a Project Engineering Leader and a Construction Manager to join its team. This international company is well-known for its pharmaceuticals and vaccines. 

What are your responsibilities?
The Project Engineering Leader is accountable of the design and execution of his projects – mainly in infrastructure/building revamping or construction by:
 

  • Partnering with engineering firms to ensure proper support in delivering the project designs & execution   
  • Working with our Business Partner to define the best solution to meet customer needs
  • Managing cost and planning for all engineering projects activities
  • Managing Basic / Detailed design and execution
  • Ensuring technical resources identified without gaps nor overlap
  • Handling project governance, budget controlling in accordance with PMO requirements
  • Overseeing the project team supervision
  • Consolidating and reviewing specifications (e.g. URS, Technical Specifications)
  • Ensuring strong communication with stakeholders and team project
  • Supporting the communication structures for full collaboration between all parties involved in engineering projects to ensure two-way communication, engagement and collaboration
  • Dealing project engineering package of medium to high complexity

     

Who are you?

  • You hold a Master’s degree in in Life Sciences (biochemistry, pharmaceutical sciences, …) 
  • Good written and oral presentation capability in English
  • You have at least 5 years of relevant experience
  • You have experience experience in (complex) projects.
  • You have experience with deployment of EPC (Engineering, Procurement and Construction) and EPCM (Engineering, Procurement and Construction Management) contracting models
  • You have excellent communication skills and ability to prioritize multiple tasks and to work on multiple projects simultaneously

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 Aurélie Montes Suarez: [email protected] or +32472/44.83.18

 

 

 

 

Qualified Person (QP) Consultant

  • Location: Braine L'Alleud
  • Type: Contracting
  • Job #20708

Qualified Person Consultant

Contracting – Brabant Wallon 
#QA #QP #Pharma 

Notre partenaire est activement à la recherche d’un QP pour completer son équipe. Notre partenaire est une multinationale connue pour ses produits pharmaceutiques. 

Quelles sont vos responsabilités?

Le domaine de l’activité en tant que QA/QP sera de s’assurer que les opérations en relation avec les matières premières et les produits pharmaceutiques importés ou fabriqués respectent les réglementations nationales et/ou internationales ainsi que les guidances (cGMP) et les polices qualité. 
Pour ce faire, voici les tâches qui vous seront confiées : 

  • Vous serez responsable de la libération et certification des lots de produits sus-mentionnés, ainsi que de la gestion des échantillons légaux
  • Vous serez garant des déviations qualité, des investigations, des CAPAs, des plaintes marché/clients, des rappels, des change controls temporaires et permanents
  • Vous serez en charge de la rédaction, revue et approbation des Product Quality Review   
  • Vous serez responsable du suivi et support QA aux projets définis par le management QA, et plus spécifiquement en lien avec les activités de release et de production.
  • Vous réaliserez des audits internes, et vous participerez aux audits clients et inspections en relation avec le champ d’activité    

Qui êtes-vous? 

  • Vous avez un diplôme de pharmacien d’industrie avec obtention du numéro de personne qualifiée (QP)
  • Vous disposez d’une expérience dans le milieu pharmaceutique GMP ou dans une position similaire, et/ou expérience en Assurance Qualité, Production ou Contrôle Qualité
  • Vous avez une bonne connaissance des réglementations internationales en lien avec les activités GMP
  • Vous êtes fluide en  français et en anglais, à l’oral et à l’écrit 

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

Quality Lead Manager

  • Location: Braine l'Alleud
  • Type: Contracting
  • Job #20714

Quality Lead Manager

Brabant Wallon – contracting 

Our partner is looking for a Quality Lead Manager to join its team. This international company is well-known for its pharmaceuticals. 

What are your responsibilities?

This position provides support to a group of Global Quality Lead professionals relative to Quality Assurance activities associated with the lifecycle management for products commercially available or in late-stage development (intermediate to Finished Product), including submissions, launches, product improvements and phase out by:
 

  • Preparing Product Change Control Committe and change controls follow-up  
  • Managing Maintenance and lifecycle of QA product flows     
  • Managing audits and inspections
  • Reviewing Annual Stability Plan  
  • Writing SOPs and other control documents
  • Managing risk management and mitigation
  • Reviewing CMC sections linked to regulatory original submissions, renewals or variations during any moment of the lifecycle management of the assigned products
  • Preparing and executing product launches from QA perspective (support in QA-RA assessment, support in QA activities, complaint readiness, shipping validation)     

Who are you? 

  • You hold a Bachelor’s/Master degree in Life Sciences (biochemistry, pharmaceutical sciences, …) 
  • You have at least 3 years experience in the pharmaceutical/biologics industry in a quality management position
  • Good written and oral presentation capability in English
  • You are able to work autonomously
  • You are able to deliver presentations or reports adapted to the audience
  • You can independently analyze data and information to draw conclusions and make effective decisions

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 Aurélie Montes Suarez: [email protected] or +32472/44.83.18 

Project Engineer Leader

  • Location: Braine l'Alleud
  • Type: Contracting
  • Job #20715

Project Engineering Leader

Brabant Wallon – contracting 

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

What are your responsibilities?

The Project Engineering Leader is accountable of the design and execution of his projects – mainly in Biologics and Injectables process and clean rooms by:

  • Partnering with engineering firms to ensure proper support in delivering the project designs & execution
  • Working with our Business Partner to define the best solution to meet customer needs
  • Managing cost and planning for all engineering projects activities
  • Managing Basic / Detailed design and execution
  • Ensuring technical resources identified without gaps nor overlap
  • Managing project governance, budget controlling in accordance with PMO requirements
  • Overseeing the project team supervision
  • Consolidating and reviewing specifications (e.g. URS, Technical Specifications)
  • Ensuring strong communication with stakeholders
  • Supporting the communication structures for full collaboration between all parties involved in engineering projects to ensure two-way communication, engagement and collaboration
  • Managing project engineering package of medium to high complexity

Who are you?

  • You hold a master’s degree
  • You have at least 5 years experience of engineering experience in investment projects in the Biologics or Injectables field
  • Good written and oral presentation capability in English
  • You are able to share good practices and knowledge
  • You have strong technical, interpersonal and leadership skills
  • You can translate customers’ needs in technical requirements

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 Aurélie Montes Suarez: [email protected] or +32472/44.83.18