Analytical Methods Validation Bio

  • Location: Wavre
  • Type: Contracting
  • Job #7583

Analytical Methods Validation Bio

Brabant Wallon – contracting 

#Pharma #QC

Our partner is looking for an Analytical Methods Validation Bio to join its team. This international company is well-known for its pharmaceuticals and vaccines. 

What are your responsibilities?

Within the Global Quality Control New Analytical Technology and Strategy department in close collaboration with local Quality Control sites around the world, you will participate to the identification, evaluation, and implementation of new or alternative analytical technologies to optimize Commercial Quality Control testing efficiency. Here are your mains tasks:

  • Organize benchmarking and technological watch to identify suitable analytical technologies focused on Automation.
  • Define plans for the evaluation of these new technologies and will lead the evaluation process by:

-Designing and organizing feasibility studies with the aim to confirm experimentally the expected theoretical benefit of the selected technology

-Designing and organizing proof of concept studies to confirm experimentally the suitability of the analytical method developed with the selected technology

  • Elaborate business case to demonstrate the economic benefits of investing and deploying this new analytical technology in the QC network.
  • Conduct experiments to support feasibility and proof of concepts studies to integrate new technologies on different QC sites
  • Closely interact with local QC sites across the network, quality, legal/IP and procurement partners

Who are you?

  • You hold a master’s degree in Biology/Biochemistry
  • You have a first experience in automation within the pharmaceutical industry
  • You have good knowledge in analytical techniques
  • You have good communication skills and are flexible
  • You are fluent (both written and spoken) in 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 Sophie Rolis: [email protected] or +32497/51.50.92

Coordinator Lab Support

  • Location: Wavre
  • Type: Contracting
  • Job #16946

Lab Support Coordinator

Walloon Brabant – Contracting

#lab #support #equipment #decomissionning #userrequirements #documentation #pharma

You have experience in the qualification of lab equipment? You are autonomous and problem solver? Keep reading the description of your future job!

Our partner is currently looking for a Lab Support Coordinator. Our partner is an international pharmaceutical company.

What are your responsibilities?

As a Lab Support Coordinator, you will be working on a laboratory equipment obsolescence project. To be successful in this role, here are your main tasks:

Operational activities:

  • User requirement writer
  • Equipment decommissioning

Coordination activities:

  • Identify constraints
  • Planning dispatching
  • Link between operation & Project Manager
  • Presentation of results, constraints, next step of the planning

Who are you?

You hold a degree in a scientific domain. You have a relevant experience in the qualification of lab equipment. An experience in HPLC is a plus. You have experience in writing documentation (ex: URS, FAT, SAT, IQ, OQ). You speak fluently French and you have a professional English. You are a good communicator, autonomous and problem-solver.

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].

Analytical Methods Validation

  • Location: wavre
  • Type: Contracting
  • Job #18167

Analytical Methods Validation

Brabant Wallon – contracting 

#Pharma #CMV

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

What are your responsibilities?

You will be the scientific analytical expert (physicochemistry) for the definition and deployment of the Continued Method Verification (CMV) program. Here are your main responsibilities:

  • Support project architect and participate in the elaboration of the overall project process steps, technical strategy and translate into deployment pilots (information gathering, build and propose scenario, present, and gather feedbacks, etc.)
  • Support QC sites in the deployment of CMV: identification of relevant test data, training on CMV tools and processes, Q&A, problem solving, …
  • Create/support the appropriate documentation to drive execution of the process steps, project execution
  • Collect and analyze the data produced and analyze the outcome in the context of the selected pilots of at the level of the overall project technical strategy
  • Participate in the definition of a program to be deployed according to pilot outcome.
  • Participate in the elaboration of the URS for the tools to be created
  • Participate in the design of a deployment strategy

Who are you?

  • You hold a master’s degree in sciences or equivalent by experience
  • You have a first experience of at least 5 years in the field of QC or analytical methods within the pharmaceutical industry
  • A strong interest in analytical data management is desired (database, data management system)
  • You have the ability to interact with statisticians and to work with data visualization tools
  • You are fluent (both written and spoken) in 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 Sophie Rolis: [email protected] or +32497/51.50.92

CQ Projects Coordinator

  • Location: wavre
  • Type: Contracting
  • Job #18159

Commissioning and Qualification Projects Coordinator

Brabant Wallon – contracting 

#Pharma #C&Q #IQOQ

Our partner is looking for a C&Q Projects coordinator to join its team. This international company is well-known for its pharmaceuticals and vaccines. 

What are your responsibilities?

As a C&Q Manager, your role include:

  • Realize the planning of your qualification’s activities and integration in project global planning
  • Coordinate outsourcing activities involved in modification projects or qualifications activities
  • Include in all project meeting as user and Technical Support representative
  • Write TCD, IQO Protocols (mechanical and process control)
  • Execute or coordinate execution of IOQ Protocols (mechanical and process control)
  • Write IOQ Reports
  • Write and drives handover certificates and punch-list

Who are you?

  • You hold a master’s degree (Biology, Biochemistry, Chemical Engineering…)
  • You have at least 5 years of experience as a CQ Engineer within the pharmaceutical industry
  • You are an expert in the field of quality/validation/verification activities
  • You are a team player, disciplined and have strong 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

Application Functional Consultant

  • Location: wavre
  • Type: Contracting
  • Job #18150

Application Functional Consultant

Brabant Wallon – contracting 

#Pharma #AGILE

Our partner is looking for an Application Functional Consultant to join its team. This international company is well-known for its pharmaceuticals and vaccines. 

What are your responsibilities?

The Functional Consultant will be the Tech lead of the Automate Planning Project and will work very close with his business counterpart. The ideal candidate has experience in planning and scheduling processes. Here are your main tasks:

  • Animate all meetings with business, users, tech people according to AGILE Methodology (Backlog Grooming, Sprint Planning, Demo, etc.)
  • Write all User Stories and review them with business and tech
  • Update with the team project documentation
  • Support business during solution demo and help building training kits for end users
  • Escalate in case of constraints / problems on the project

Who are you?

  • You hold a master’s degree
  • You have a first experience as a project leader (planning, workshop preparation and lead)
  • You have good in production, planning and SAP
  • You have good knowledge of AGILE methodology
  • You are a team player, disciplined and have strong 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

Deviation and CAPA Specialist

  • Location: wavre
  • Type: Contracting
  • Job #18016

Deviation and CAPA Specialist

Brabant Wallon – Contracting

#Pharma #CAPA #QA

Notre partenaire de l’industrie pharmaceutique connu pour ses vaccins est à la recherche d’un Deviation and CAPA Specialist pour intégrer son équipe.

Quelles sont vos responsabilités?

Apporter un support pour la gestion départementale des déviations et CAPA. Voici quelques unes de vos tâches:

  • Clôture CAPA (activités opérationnelles dans le système SAP)
  • Clôture déviation (activités opérationnelles dans le système SAP)
  • Support au département pour la simplification des modes de gestions déviations et CAPA
  • Suivi des plans de formation des CAPA et Déviations
  • Support aux équipes pour l’implémentations des bonnes pratiques déviations et CAPA

Qui êtes-vous?

  • Vous possédez un master Scientifique ou équivalent par experience.
  • Vous bénéficiez d’une première expérience dans le management des deviations et CAPA dans l’industrie phamraceutique
  • Vous avez une bonne connaissance des GMP
  • Vous aimez travailler en équipe et êtes orienté qualité

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

Process Engineer

  • Location: wavre
  • Type: Contracting
  • Job #17960

Process Engineer

Brabant Wallon – contracting 

#ATEX #Pharma

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

What are your responsibilities?

  • Support process safety risk assessments
  • Support customers to deploy mitigation plans for Process Safety High Severity Risks
  • Support customers in the deployment of asphyxiant and other dangerous gases risk assessments
  • Support action plan definition and deployment to reach acceptable risk levels
  • Give support to apply ATEX regulation to MPUs/SPUs (participation in the risk assessment and zoning definition, action plan deployment, support maintenance plan definition, document storage)
  • Support customers in chemical storage design and routine management (gap assessments with external and internal regulation, action plan deployment, support to maintenance plan definition)
  • Support customers in incident investigations, troubleshooting and projects in the expertise areas
  • Lead L2 audit

Who are you?

  • You hold a master’s degree in Electromechanical Engineering
  • You have a first experience within the pharmaceutical industry (GMP)
  • You have a technical safety background
  • You are pragmatic and have good communication skills
  • 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. Do you have any questions? You can contact Sophie Rolis: [email protected] or +32497/51.50.92

Maintenance Engineer

  • Location: Wavre
  • Type: Contracting
  • Job #17716

Ingénieur Maintenance

Brabant wallon – Contracting 

#Pharma #GMP #Junior #Engineer #Ingénieur #Maintenance

Notre partenaire, une entreprise internationale connue pour le développement et la production de vaccins, recherche un Ingénieur Maintenance pour renforcer ses équipes.

Vos responsabilités ?  

  • Support à l'équipe maintenance opérationnelle (analyse des problématiques,
    fonctionnement équipements)
  • Gestion des ordres de travail (évaluation complétion des intervention, clôture,
    analyse backlog)
  • Gestion de déviation ;
  • Gestion de CAPA
  • Suivi système d'alarmes AMS
  • Optimisation de la gestion des interventions

Votre profil?

  • Formation Ingénieur (électromécanique,…)
  • Vous avez une première expérience en industrie pharmaceutique 
  • Vous avez des connaissances en GMP ainsi que des connaissance en déviation et système qualité.

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.

Intéressé(e) ? N'attendez plus !

Postulez directement via notre site WWW.JEFFERSONWELLS.BE ou envoyez votre CV à l'adresse mail suivante [email protected]

QA CSV

  • Location: Wavre
  • Type: Contracting
  • Job #17702

QA CSV

Walloon Brabant – contracting

What are your responsibilities?

  • Writing, reviewing and approving of validation plans and validation summary reports
  • Reviewing and approving of design documentation (TCD, ERES, URS, DQ, …)
  • Reviewing and approving of qualification protocols and reports (IQOQ & PQ)
  • Writing and reviewing of Periodic Review Reports (PR)
  • Reviewing and approving of CSV specific documentation (inventory, …)
  • Reviewing of CVS specific SOP’S and Templates
  • Ensure the proper execution of the qualification and validation activities with respect of the internal validation methodology to maintain the validated status of automated and computerized systems.
  • Ensure QA activities on quality systems (CAPA, Deviation, Change Control, …) related to automated and computerised systems.
  • Support team and management during internal and external audits

Who are you?

  • University (Master) degree in Sciences / Biological Engineering (e.g. Pharmacist / Master in Sciences / Bio Engineer)
  • Certification in computer system validation or equivalent is a plus.
  • Experience in a computer systems validation role
  • CGMP and specific regulations and guidelines applicable to computerized and automated systems (GAMP, Eudralex Vol 4 annex 11, 21 CFR part 11, …)
  • Validation practices and guidelines (life cycle approach, ICH, ASTM E2500, …)

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 invite you to apply !

Do you have any questions? You can contact Anaïs Malikian, [email protected]  

Compliance QA/RA Expert

  • Location: Wavre
  • Type: Contracting
  • Job #17689

Compliance QA/RA Expert

Walloon Brabant – contracting

What are your responsibilities?

  • QA oversight for regulatory compliance change controls
  • QA oversight for compliance risk assessment reports.
  • The completion of regulatory advice 1 assessments for multi-sites change controls.
  • The timely delivery of the global documentation (e.g. SOPs) updates linked to the site conformance and regulatory compliance processes in compliance with internal requirements.
  • Participate as global site conformance partner for Global Supply Chain change control boards.
  • Act as global site conformance role to deliver and implement initiatives and improvement programs management
  • Ensure the continued compliance of the company products versus registered details in collaboration with local Site Conformance network and technical regulatory department across the whole organization
  • Ensure close collaboration with global and regional regulatory affairs teams by provide quality oversight to the CMC regulatory processes such as building of regulatory dossiers and management of regulatory approval conditions
  • Ensure quality culture and mindset, through participation as QA partner to RA initiatives aimed at improving the end-to-end CMC process (e.g. the Regulatory Submission Building Process task force, etc).
  • Driving alignment across site conformance network through site conformance network meetings and workshops.
  • Lead project-related discussions and provides in-depth strategic, scientific and RA input for technical/CMC and procedural aspects.

Who are you?

  • Preferably PharmD with master degree in regulatory affairs or quality
  • At least 6 years of experience in Quality & Regulatory domains (pharma/vaccines industry)
  •  Knowledge of Vaccine regulatory, quality, testing and/or manufacturing environment, preferably
  • Strong knowledge of regulations, guidance's and industry standards related to CMC processes
  • Quality mindset with good knowledge of pharmaceutical operations (including manufacturing and testing of vaccines) and Quality Systems, Good Manufacturing Practices (GMP) as well as Regulatory matters
  • Demonstrated expertise and knowledge of regulated environment (CMC or GMP) in vaccines industry
  • Excellent project management expertise, with level of accountability, and drive for success.
  • Excellent written and spoken English is a must, French is an advantage

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 invite you to apply !

Do you have any questions? You can contact Anaïs Malikian, [email protected]