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.
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 therelease 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 standardsin 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
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
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
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.
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.
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
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
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
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
