External Operations Quality Partner Brabant Wallon – Contracting What are your responsibilities?
Batch record review and administrative support (e.g., updating CoC, handling deviations, complaints, temperature excursions).
Provide timely and efficient GMP/GDP IMP Release function to all relevant internal project activities related to the development of the pipeline projects
Support compliance with all relevant and appropriate regulations and guidelines, such as those relating to GMP/GDP, health and safety, etc..
Support the systems and processes in place for the appropriate documentation of internal development activities and to maintain them in a manner compliant with regulatory and corporate requirements.
Ensure the Clinical Supply Quality activities are consistent across the range of different environments and teams supported (Vendors / Suppliers / in house).
Proactively support the activities of Clinical supply for relevant manufacturing quality systems (deviation close out / Change management / complaints / quality improvement).
Identify and facilitate resolution of technical and manufacturing quality issues that may impact the quality of the CMC sections of regulatory submissions.
Provide support in the evaluation of Temperature excursions for IMP.
Management of Quality Complaints of IMP.
Ensure active participation in the selection, evaluation, approval and maintenance of Vendors for IMP activities, including leadership or support to conduct appropriate audits.
Oversight of Distribution activities (deviations, Business Review Meetings, assessments, etc…)
Ensure CMO (packaging and distribution vendors) quality documentation is accurate and up-to-date, by editing and reviewing quality agreements
Contribute the preparation of audits (internal/external, regulatory inspections)
Lead internal audits / Self-Inspections
Who are you?
5 years’ experience in QA/compliance experience in pharmaceutical regulated environment
Good knowledge of cGMP and relevant regulatory requirements (e.g US, European, Japanese)
Strong experience in batch review.
Quality mindset with a pragmatic and proactive approach.
Fluent in English is a must and French is a nice to have.
Experience working with CMOs and vendors.
Familiarity with GMP and GDP standards.
Experience with quality systems (deviation management, complaints, change control)
Familiarity with clinical packaging environments (vs. commercial) is a plus
Certified auditor status is a plus.
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!
Perform analyses on raw materials, intermediates, and finished products (stability, IPC, clinical release, investigations).
Develop and validate analytical methods for different phases of product development.
Ensure stability and clinical release testing for phases I and II.
Participate in analytical method transfers to QC and subcontractors.
Use lab software: Empower (Waters), GLIMS, e-noval, Veeva.
Analyze results with a critical mindset, ensuring consistency with previous data.
Follow procedures, use validated methods, and maintain analytical equipment.
Work under the supervision of a project scientist, collaborating with – Chemical Process R&D and Drug Delivery Design teams.
Must-Have Qualifications:
3 to 5 years of experience in analytical chemistry (small molecules).
Bachelor’s degree in analytical chemistry.
Technical expertise: HPLC/UPLC, GC, detection via UV/Vis, RI, MS.
Familiarity with USP/EP pharmacopoeias.
Proficiency in Empower software (mandatory).
Strong critical thinking, scientific curiosity, and ability to challenge results.
Good understanding of technical written English.
Experience in the pharmaceutical industry.
Familiarity with other chromatography data systems.
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 or send me your CV, [email protected]
Facilitate interactions between Global sterility assurance and the CMO under its responsibility by establishing working relationship (Service Level agreement using Key Performance Indicators) with the leaders and main contact people.
Act as a main point of contact for the CMO in supporting the implementation of the client Sterility Assurance Strategy
Is the point of contact for supporting the CMO in the establishment of the annual Contamination Control Strategy or Sterility Assurance Road map
Support CMO in the execution of the annual CCS in the different sterility assurance domains and processes (training, trouble shooting, coaching/mentoring, specific projects) and perform process confirmations on targeted topics
Partnership with CMO for Key Performance Indicators analysis, trending and escalation, gap assessment versus standards including (Sterility Assurance GQP's and QMS, FDA Guidance, etc.)
Review with CMO the annual performance in Sterility Assurance and help on the preparation of the next CCS
Assure availability of Sterility Assurance experts for supporting CMO in a specific domain according to annual CCS priorities.
Accountable for alignment in way of working and standard works between CMO in Sterility Assurance subjects.
Is the Sterility Assurance quality generalist and therefore act as SPOC 9Single Point of Contact) in case of issue/question raised by the CMO.
External advocacy: Lead or influence proactively Sterility assurance external trade associations.
Developing Capability: Supporting the development of sterility assurance capability across key areas of the business through delivery of training, coaching and mentoring.
Why you?
Bachelor degree in a Scientific Discipline
Significant experience in aseptic or bioburden control manufacturing environment (production, QA, validation) with demonstrated successful results, preferably in FDA regulated environment
In depth knowledge of regulations, guidance, best practices and industry standards related to sterility assurance (for example: GMP, WHO, PDA, ASTM, ISPE, PhRMA, etc.) including review of regulatory files
Strong technical and quality skills in sterility assurance issue
Coaching and mentoring capabilities for shopfloor training and education
Strong verbal and written English language skills & French
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 or send me your CV, [email protected]
Déploie efficacement des projets en collaboration avec les différents acteurs en place, en assurant une coordination optimale et une synergie entre les équipes.
Développement de solutions scientifiques pour optimiser les processus
Identifier, analyser et gérer de manière proactive les risques associés au projet.
Organiser et leader le Steering Committees pour le projet, les PRB, les réunions d’alignement.
Développer et promouvoir une vision stratégique claire pour les projets, en tenant compte de l’évolution des besoins de l’entreprise.
Assurer une communication fluide et efficace au sein du projet ainsi qu’avec les stakeholders, en adaptant les messages selon les audiences.
Garantir le suivi des indicateurs de performance du projet et des projets associés
Piloter la gestion du budget du projet, en garantissant un suivi des dépenses et en élaborant des projections pour les années futures
Principaux projets : 1- Projet de validation et qualification d'une nouvelle tour de chromatographie (validation et qualification, implémentation de l'équipement en production) 2- Projet DOE élution allongée (test à petite échelle de l'effet cumulé des élutions allongées QXL HA sur le rendement et l'élimination des impuretés)
Votre profil:
Capacité démontrée à acquérir rapidement des connaissances sur des sujets nouveaux dans un environnement complexe et en constante évolution.
Capacité à faire valoir le positionnement scientifique basé sur des évidences.
Aptitude à s’intégrer facilement dans des équipes pluridisciplinaires et à collaborer avec des parties prenantes variées.
Expérience avérée dans la gestion de projets complexes, avec une expertise particulière dans les domaines du process et de la validation dans l’industrie pharmaceutique.
Proactivité et capacité à anticiper les besoins du projet, en prenant des initiatives pour garantir son succès.
Sens critique et capacité à gérer des priorités multiples dans un environnement dynamique.
Orientation résultats, avec un sens de l’organisation et de la gestion des délais.
Capacité à synthétiser les messages clés pour le management.
Notre offre : Jefferson Wells vous propose un contrat à durée indéterminée (CDI) en tant que consultant, assorti d’un package salarial attractif. Nous serons votre partenaire de carrière à chaque étape de votre parcours professionnel. Intéressé(e) par cette opportunité ? Nous vous invitons à postuler ou à m’envoyer directement votre CV à l’adresse suivante : [email protected]
Lead various ongoing projects related to the implementation of new analytical equipment (computerized and non-computerized) in-line data integrity requirements and Good Science Practices (GSP), Good Manufacturing practices (GMP).
Prepare documentation (protocols, reports, URS, user guide/SOPs and other qualification -related documents)
Support system owner (SO) / Process Data Owner (PDO) in the following task:
Identifying critical data and critical steps throughout the business processes
Defines appropriate processing of data in accordance with data integrity principles
Ensures that equipment (CS and non-CS) is fit for purpose
Determines access criteria and related restrictions
Support the definition of data flows and archiving strategy
Be the Single Point of Contact (SPOC) for analytical-related equipment for Engineering team, engineering of fice and equipment CQV team
Follow the GMP/GSP procedures in place as well as the Biosafety/HSE rules in the laboratory
Work in close collaboration with users, IT, qualif/valid, engineers and GMP/GSP QA experts
Work according to the agreed timelines
Your profile:
Master's Degree
Demonstrate a high level of autonomy, flexibility and a proactive mindset.
Ability to communicate effectively with good French and English skills
Technical knowledge analytical techniques required to study viral vector Gene Therapy Products is an asset (UPLC, Mass spectrometry, light scattering, electrophoresis, qPCR, spectrophotometry , …
Experience in GMP/GSP analytical equipment qualification and release (URS and SOPs writing, validation documentation review, …)
Ability to multi-task and to openly exchange results, observations, and possible improvements
Demonstrate ability to analyze data, with good attention to detail, and excellent record keeping and documentation
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 or send me your CV, [email protected]
Bioprocess System specialist Contracting – Brabant Wallon Your Responsibilities:
Handle troubleshooting in production, particularly when issues arise with cleaning or production equipment.
Participate in task force meetings to address and resolve production-related problems.
Work on multiple projects simultaneously, with tasks changing depending on the project's phase.
Review documentation during the early stages of projects, and visit production areas to monitor CIP (Cleaning in Place) sites to ensure all systems are functioning properly.
Be adaptable, as each day varies greatly based on the needs of ongoing projects.
Your Profile:
Experience: A minimum of 2 years of experience in a pharmaceutical company, specifically in cleaning process equipment. Experience in USP or DSP processes is a plus, as long as you have a basic understanding of pharmaceutical equipment cleaning requirements.
Pharma Experience: Strong background in the pharmaceutical industry is a must, ideally with a focus on clinical operations. Candidates with cleaning experience are preferred. Pharmaceutical experience is critical as training on GMP zones, attire, and behavior can be time-consuming.
Autonomy & Proactivity: You must be able to work independently without constant supervision. The team is looking for someone who is proactive and can handle challenges autonomously.
Experience with managing deviations and investigations, handling change control, implementing CAPAs (Corrective and Preventive Actions), and developing cleaning strategies is highly valued.
Languages: French proficiency is essential for daily communication, as most protocols and reports are in French. While basic English skills can be helpful, English is not required for the role.
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 or send me your CV, [email protected]
Quality Partner Brabant Wallon – contracting Your responsibilities?
This team manages the quality of products distributed internationally through subsidiaries or commercial partners. The QA Partner acts as the main quality contact between the company and its partners, ensuring bilateral communication and compliance with quality agreements.
Act as the main quality contact between the company and commercial partners.
Manage quality complaints received from partners.
Handle deviations (e.g., temperature excursions, damaged products).
Monitor and assess Change Controls and notify partners when necessary.
Work autonomously on a portfolio of partners while collaborating with the team.
Your profile?
You have a Scientific or Engineering Degree (or equivalent acquired through professional experience)
Minimum 2 years experiences in Quality Assurance in a pharmaceutical environment
Experience in managing external suppliers or partners.
Knowledge of quality agreements.
Proficiency in handling complaints, deviations, and Change Control processes.
Good command of English (main working language).
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.
Logistic Compliance and Process Excellence Manager
Contracting – Brabant Wallon
Your responsibilities:
Manage and lead the backlog of deviations to resolution.
Understand the deviations, logistics and warehousing processes, to understand the description and history of each issue, including the work done so far.
Build and lead suitable teams for efficient collaboration
Conduct comprehensive root cause analysis to accurately identify the source of each issue.
Collaborate with stakeholders to develop and implement action plans that prevent recurrence.
Challenge existing analyses and conclusions where necessary, ensuring accuracy and completeness.
Coach the current logistic team, enhancing process understanding and their capability in handling their responsibilities, deviations and root cause analysis.
Your profile:
Bachelor's Degree
Strong experience in dealing with deviations and performing root cause analysis.
Extensive experience with GMP warehouse management and inventory systems (SAP)
Experience in coaching junior team members, enhancing their skills and effectiveness.
Proven ability to challenge existing work and provide accurate, complete analyses.
Ability to manage and challenge the content of deviations and engage in productive discussions with stakeholders.
Maturity, dedication, and the right mindset to drive continuous improvement.
Excellent analytical and problem-solving skills.
Strong communication and interpersonal skills.
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 or send me your CV, [email protected]
Pour notre client spécialisé dans le secteur de l'industrie lourde, nous sommes activement à la recherche d'un Ingénieur Fiabilité dont la mission principale sera d’assurer la performance, la fiabilité et la durabilité des équipements, systèmes et processus. L’objectif est clair : réduire les arrêts imprévus, améliorer la sécurité et maximiser l’efficacité opérationnelle.
En tant qu’ingénieur fiabilité, vous serez responsable des actions suivantes :
Analyser les données opérationnelles et les tendances afin de détecter les risques de défaillance ou de dysfonctionnement
Élaborer et mettre en oeuvre des plans de maintenance efficaces (préventive, conditionnelle, prédictive)
Définir des mesures pour améliorer la sécurité, réduire les coûts, raccourcir les délais de réparation et allonger les cycles de maintenance
Organiser l’évaluation technique des équipements à partir des diagnostics et des retours d’expérience terrain
Mener des analyses de causes racines en cas de panne
Piloter la création et la mise à jour des arborescences d’équipements et des nomenclatures dans les systèmes de GMAO (SAP PM, MM)
Travailler en étroite collaboration avec les équipes d’ingénierie, de production et de maintenance pour améliorer la fiabilité globale
Appliquer les méthodes et outils d’ingénierie de la fiabilité (FMEA, FTA, etc.)
Suivre les indicateurs de performance et formaliser les plans d’amélioration continue
Former et accompagner les équipes aux bonnes pratiques de fiabilité
Qui êtes-vous ?
Diplôme d’ingénieur, idéalement en fiabilité, mécanique ou électricité
Solides compétences techniques en mécanique et hydraulique, ainsi que de bonnes bases en électricité et instrumentation
Une certification professionnelle en fiabilité (CRE, CMRP…) est un atout apprécié
Expérience avérée en application de méthodes de fiabilité (FMEA, FTA)
Connaissance des normes industrielles en qualité et fiabilité
Expérience dans la mise en oeuvre de programmes de maintenance préventive et prédictive
Compétences en gestion de projet orientées fiabilité et amélioration continue
Maîtrise des outils de GMAO (SAP PM, MM) et des outils d’analyse de données
Capacité à travailler en transversal avec des équipes pluridisciplinaires
Leadership affirmé, bonne communication, sens de l’organisation et esprit d’initiative
Sens du service, orientation client et goût du travail en équipe
Que pouvez-vous espérer ?
Jefferson Wells vous propose un contrat à durée indéterminée (CDI) en tant que consultant, assorti d’un package salarial attractif. Vous aurez accès à des formations techniques et en compétences comportementales (soft skills). Nous serons votre partenaire de carrière à chaque étape de votre parcours professionnel.
Intéressé(e) par cette opportunité ? N'hésitez pas à postuler !
Ability to direct projects, manage different project phases and coordinate project team.
Responsibility for projects and assistance to stream lead and client.
Responsible for obtaining optimal results on completion of project achieving quality, performance, cost and scheduling requirements required in the specifications.
Has specialized technical or practical expertise in one or more areas and knowledge of project management software and method.
Your profile:
Experience in project management
Experience in Product & Process
Consultant is expected to follow and apply project management methodologies, tools and practices which are based on PMBOK Knowledge: · Demonstrates competency in project management software and methods
Successful experience in stakeholders management
Proven Project Management experience with capability of working independently on multiple projects, and ability to prioritize tasks and meet strict deadlines
Excellent organization skills and ability to operate effectively in a multicultural, matrix organization where the workload requires balancing multiple responsibilities simultaneously
Establish and maintain cross functional relationships. Develop relationships across organizational boundaries
Analytical, logical thought process with strong information organization/management skills.
University degree with experience in project management
Prince II, SAP, Suite office
French & 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 or send me your CV, [email protected]
