Our partner is looking for a GlobalQuality Lead Devices to reinforce its teams. Our partner is a well-known pharmaceutical industry.
Your responsibilities?
Design and development Quality assurance
Oversee Design & Development activities, from Inputs definition through Design Transfer (including Validation/Verification activities)
Review and approve relevant sections of the device design control documentation and/or Technical Documentation File as required
Review and approve protocols and reports for Verification & Validation studies, technology transfers, stability studies, etc…
Review and approve internal documentation. Ensure Design History File (DHF) is in place
Support Risk Management Activities related to devices. Ensure risk assessments are performed at appropriate stages of development/commercialisation and for decision making on issues arising.
Ensure deliverables are issued in accordance with the D&D plan
Review and approve submissions and responses
Vendor quality management
Accommodate design & technology transfer and ensure systems alignment between vendor and the company
Performing focused assessments/audits
Preparation and negotiation of Quality Agreements
Ensure systems alignment between vendor and the company
Facilitate quality improvement activities at vendors and company systems
Support risk register for the vendor, and follow up on mitigation activities
Monitor and trend vendor performance
Authority to accept release or block release of Medical Devices
Oversee inspection plans at CMO and the company
Quality processes
Facilitate investigations and resolution of issues relating to deviation and change management
Review and approve deviations
Lead/review critical investigations
Track CAPA events and closure
Oversee/track change controls
Your profile?
Minimum of 5 years working in the pharmaceutical/biologics/medical device industry in a quality management position.
Operational GMP experience or clinical activities experience would be a distinct advantage.
Practical understanding of ISO 13485:2016, MDR, ISO 14971 and 21CFR820 and part 4 requirements.
Should have a US and EU knowledge of pharmaceutical and medical devices regulations together with quality principles and techniques.
Take accountability for decisions and actions taken.
Be proactive, confident and enthusiastic during the interaction with colleagues during team work and take the initiative to promote and share/implement best practices.
Must possess good interpersonal, verbal, and written communication skills and be able to confidently present information at interdepartmental and external meetings. Ensure free flow of information throughout the sphere of work.
Root cause analysis and risk management/assessment skills will be a distinct 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.
Project coordinator and Peptide Subject Matter Expert
Brabant Wallon – contracting
#Pharma #DS #API
Our partner is looking for a Project coordinator and Peptide SME to join its team. This international company is well known for the research, the development, and the commercialization of its pharmaceutical products.
What are your responsibilities?
The Project Coordinator Drug Substance and Subject Matter Expert (SME) will be responsible for the supervision and coordination of all external API activities. Here are your main tasks:
Represent technical DS during internal and external meetings and liaise with key stakeholders.
Functional representative (DS) in the Vendor Team as a CPR&D member
Co-develop and coordinate integrated functional project development and plans for DS and
consolidate project related work packages (internal and external) that are delivered
through the different departments
Integrate all aspects of DS, Biologics, and Analytical, to ensure that work packages (internal
and external) are initiated, executed and delivered to meet project timelines, milestones
and deliverables,
Identify, communicate, and manage risks associated with the assigned project and to
develop appropriate mitigations.
Proactively plan, track, drive all DS related activities and expenditures in their area of accountability ensuring full adherence quality and timelines ensuring any deviations are appropriately escalated.
Responsible for risk management for assigned project(s) within the function ensuring all major risks are identified, reported, escalated, and adequately mitigated
Ensure proactive and timely stakeholder management
Provide scientific leadership and project management for the assigned project based on phase of development and complexity.
Contribute to the coordination and review of relevant source documentation from technical function as required for filing/submission and actively support the registration processes.
Accountable for defining and implementing an integrated DS strategy in collaboration with SMEs functional line management and in alignment with the overall CMC strategy for assigned project(s).
Oversee Drug Substance development and manufacturing operations. Oversee process optimization, qualification batch manufacturing and process validation and coordinate the technical preparation for the PAI.
Proactively identify process issues and work collaboratively within the company and the CMO to address challenges.
Facilitate and support technology transfer activities at CRO/CMO.
Provide guidance to manufacturing, CMC and QA to ensure compliance with all applicable regulations and assist in resolutions of issues identified.
Identify and report deviations as appropriate, and typically work to resolve more complex deviations.
Responsible for authoring technical reports that are the basis of future CMC DS sections of regulatory dossiers and responsible for providing responses to regulatory inquiries.
Who are you?
You hold a PhD or a master’s degree with minimum 5 years of experience in a GMP environment
You have an experience in Late Stage of Development and/or in peptides
You are a good communicator and a team-player
You are fluent in English. French is a plus
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
Our client is looking for a Project Manager Digital Laboratory to reinforce its teams. Our client is a well-known pharmaceutical industry.
What are your responsibilities?
As Project Manager Digital Laboratory, you will ensure the management of laboratory digitalization projects/program from initiative to closure. You will ensure with the Business Glims solution expert that the Labware system is built fit for use and maintained in a way that it supports the various laboratory analytical processes in an efficient and effective manner. To be successful in your role, here are your main tasks:
1 – Projects management:
Lead and ensure delivery in time, in quality and in budget of projects under scope from beginning to end.
Organize project’s structure and governance, manage related meetings (Steering Committee, Core Team, Streams). Ensure alignment and agreements are there along project delivery.
Collaborate with IT & vendor project managers to coordinate the activities of our client:
Business stakeholders (subject matter experts, compliance & QA representatives from discovery, technical development, and quality control departments),
IT teams (system owners, infrastructure, security, validation, etc.),
External partners (e.g.Labware experts).
Being influential, make sure that everyone appropriately contributes to the delivery of the project on time, in full and with quality (incl. proper reporting, risk & issue management).
More specifically, lead the gathering & formalization of user requirements (incl. process & data flows and metadata management), the acceptance testing & performance qualification of the delivered solution and the training of end-users, guaranteeing that our needs are properly defined (and aligned across departments) and supported by the final product.
Specific to Glims related projects, able to support Business solution role for all projects impacting directly (new modules, new version) or indirectly (new interfaces, data interchange with other systems like DARTH) the Labware LIMS
2 – Support to Business lims Solution Expert:
Ensure consistency of LIMS data structure across processes and in its connectivity with other systems (SAP, LDMA, ELN, …)
Ensure that systems knowledge, settings, table structure and data logic are adequately documented and maintained.
Evaluate side effect of any proposed modification (change requests, new projects) to the Labware system on laboratory business processes.
Provide, when required, expertise in the modules in order to improve it as much as possible, which can include revamping, standardization and alignment of processes, proposals to IT to improve the technical design; but also writing of procedures, trainings and coaching of local key users.
Ensure requested development to IT are matching business requirements by testing in depth new functionalities in systems.
Regarding Glims projects:
Define, Validate and review requirement specifications, and support design of the solution from a business perspective
link business needs and IT constraints in projects, to deliver lean processes within the modules.
Review and validate functional specifications of the solutions
Plan, define and support appropriate User Acceptance Test
Build training material or coordinate with local key user
Who are you?
You hold a master’s degree and you have a APICS or PMI certification (or demonstrated knowledge of project management methodology).
Proven experience in transversal project management
Experience with Labware LIMS system
Experience in QC activities, analyses and processes (min 2 years)
Experience in system interfacing
Experience in data management
Experience in interdepartmental interaction (business, IT, QA)
Demonstrated experience in project management
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]
Our client is looking for a LIMS Support Specialist to reinforce its teams. Our client is a well-known pharmaceutical industry.
What are your responsibilities?
As a LIMS Support Specialist, your main tasks will be:
Main activity: ensure Labware LIMS static data readiness in support to a project:
Configuration and qualification of all products & material analytical specifications and related analyses.
Configuration and qualification of environmental monitoring, sampling plans, configurations IPC related to a project.
Secondary activity: support to operational activities of the LIMS partner team:
Analysis of incidents related to LIMS sent by QC / DEV laboratories
Search and identification of root cause and proposal of solution to avoid reoccurrence (both from a process and technical point of view).
Determine whether an incident need to be resolved by the LIMS admin or by the IT team.
Implement changes not requiring a static data qualification.
Transfer incidents to the IT team.
Test solutions implemented by IT.
Participate the weekly follow-up meeting with IT LIMS team.
Support end-users on specific requests (e.g. data extraction, implement queries in the LIMS).
Manage access to LIMS system.
Who are you?
Bachelor / Master (preferred) in Sciences (chemistry / biology)
Mandatory strong knowledge of static data configuration of the Labware LIMS system (analytical specifications, analyses, In Process Control)
Strong knowledge of the QC laboratory analytical activities to fully understand the static data requirements
Knowledge of data management and relational DB (ability to query DB in SQL is an asset).
Ability to communicate in English with both IT and Business Departments.
Ability to follow several activities in parallel.
Ability to work in partnership with several departments.
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]
Vous êtes la recherche d'un emploi de Project Manager ? Vous êtes une personne curieuse et volontaire ? Notre partenaire est une société à portée mondiale active dans la maintenance d’équipements industriels.
Objectif : le Project Manager entretient et développe l’activité commerciale d’un « portefeuille clients » qui lui est proposé par son Business Unit Manager (BUM), et assure le processus commercial, organisationnel et technique complet auprès de ces clients, en veillant particulièrement à la planification efficace des travaux, à l’affectation optimale des ressources, et à l’obtention des marges fixées par son BUM et la Direction Générale.
Quelles sont vos responsabilités ?
Sécurité – Environnement Qualité
Le Project Manager Senior :
Définit, avec l’équipe de management, le plan annuel et quinquennal et veille à sa réalisation.
Assure la promotion et la mise en œuvre de la politique sécurité de l’entreprise au sein de son département.
S’assure, pour lui-même et pour l’ensemble de ses collaborateurs, de la réalisation des actions qui visent à la diminution des risques dans l’entreprise, ainsi qu’à l’amélioration des conditions de bien-être au travail.
Veille à la mise en place des moyens nécessaires à l’obtention et la vérification des formations, habilitations et permis nécessaires pour l’ensemble du personnel concerné.
Veille à la mise en place des moyens nécessaires à la remontée des informations en matière de sécurité, d’incident, de déviation aux règles de sécurité et veille à les diffuser à ses collaborateurs.
Rédige les documents tels qu’autorisation de travail, ouverture de chantier, Modes Opératoires.
Gestion commerciale
Participe à la réflexion stratégique en étroite collaboration avec son BUM.
Cherche à augmenter le chiffre d’affaires et la rentabilité de son « portefeuille client ».
Démarche des nouveaux clients, en accord avec son BUM et conformément aux plans d’actions
Assure le remplacement de son BUM dans les réunions de prospection si nécessaire.
Gestion financière
Consulte et analyse régulièrement son compte de résultats prévisionnels.
Analyse ses propres indicateurs, en assure le suivi, et en déduit des plans d’actions efficaces.
Participe de manière active au suivi financier de la Business Unit (réunions)
Gestion des ressources humaines
Participe activement à la vie de l’équipe de la Business Unit et assume activement les rôles et responsabilités proposés par le BUM.
Mesure et évalue sa propre charge de travail, son efficacité et sa rentabilité, conformément aux objectifs de l’équipe.
Pilote ses équipes et participe activement aux processus d’évaluation du personnel occupé dans le cadre de ses chantiers.
Gestion opérationnelle
Est le garant de la bonne application du processus de gestion de projet.
Effectue les tâches suivantes dans le cadre du processus commercial, organisationnel et technique complet auprès de ses clients :
la préparation, la négociation et le suivi des offres
le suivi des commandes sur le plan budgétaire
la planification des travaux et la réquisition des ressources dans les meilleurs délais
la production et le suivi des décomptes intermédiaires et finaux
l’établissement, la négociation et le suivi des offres de prix complémentaires
la préparation et le suivi des dossiers de facturation
la vérification de la clôture administrative et physique des projets
le suivi du paiement des factures et l’apurement des retards
l’examen des pertes et déclassement de matériel
l’évaluation du projet, la mise en place et le suivi des plans d’actions, et la communication des retours d’expériences.
Veille à l’obtention des couvertures de risques nécessaires (assurance crédit, assurances chantier particulières, etc..).
Qui êtes-vous ?
Vous disposez d’un master ou expérience assimilée. Formation technique en construction métallique, mécanique ou électromécanique.
Vous avez une expérience probante de dix années en maintenance ou projets industriels dans les domaines décrits ci-dessus .
Vous êtes meneur d’hommes, obsédé par la sécurité des hommes, Problem solver. Rigoureux, et organisé. Disponible et flexible. Vous êtes orienté(e) « client » et « amélioration continue ».
Vous avez une connaissance de la suite Office.
Que pouvez-vous attendre ?
Dans cette fonction, notre partenaire entend :
Vous donner l’opportunité de vous développer au sein d'une société faisant partie d'un groupe international.
Vous démontrer que la culture de son entreprise se caractérise par une atmosphère informelle et conviviale.
Vous fournir une formation car la croissance et l’évolution des talents sont des éléments importants pour notre partenaire.
Vous vous reconnaissez dans cette description ? N’hésitez pas à postuler !
Notre partenaire est activement à la recherche d’un Superviseur de chantier HVAC pour supporter un projet de rénovation de plusieurs bureaux dans une mutltinationale pharmaceutique. Notre partenaire est un expert en HVAC, ses projets couvrent toutes les étapes des installations et le suivi de leur conformité.
Quelles sont vos responsabilités?
S’assurer de la bonne avancée du projet sur le remplacement des HVAC
Superviser les ouvriers
Gestion du planning
Gestion des documents adéquats au chantier (permis de travail, sécurité, suivi du chantier…)
Collaborer avec l’ingénieur de projet pour revoir les plans, identifier et proposer des solutions aux éventuels problèmes
Vous serez l’interface entre le client et notre partenaire
Qui êtes-vous?
Vous avez un bachelier ou une experience en HVAC
Une experience en gestion de chantier et d’ouvriers
Vous êtes un bon communicateur et négociateur, vous avez une bonne capacité de planification et à résoudre des problèmes.
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 Sophie Rolis : [email protected] ou +32(0)497/51.50.92
