Our partner is looking for an Validation Engineer to join its team. This international company is well-known for its pharmaceuticals and vaccines.
What are your responsibilities?
You will be responsible for managing and executing product transfers to Contract Manufacturing Organizations (CMOs) in the United States, particularly for secondary activities such as filling, visual inspection, and finished product packaging.
Responsibilities:
Assess the maturity and validation level of CMOs, including the analysis of differences in validation strategies.
Draft and review validation plans, including those of the CMO.
Write leveraging documents and difference analyses concerning the CMO's validation strategy.
Review and approve validation protocols and reports.
Verify validations included in the submission file and the CMO’s validation summary reports.
Provide technical support, maintenance, and troubleshooting at the CMO.
Who are you?
Convincing experience in the field of validation.
Strong communication skills and excellent proficiency in both French and English (project involving sites in the USA and Italy).
Ability to work in a matrix organization.
Experience with CMOs and in filling and visual inspection activities is a plus.
Previous experience at GSK is highly appreciated.
Skills and Assets:
Excellent communication and teamwork skills.
Perfect bilingual proficiency in English and French.
Ability to assess and analyze CMO validation strategies.
Aptitude for rigorously drafting and reviewing technical validation documents.
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.
The QA Spare parts is part of the QA for Technical Services. They ensure the QA oversight of the spare parts warehouse.
The responsibilities – Release spare parts to be used on GMP equipment throughout company plant. – Contact the spare parts' supplier in case of further investigation to allow release of the spare parts. – Ensure on the floor presence and be the point of contact for the operational team. – Participate to the strategy definition of the spare parts management and release. – Ensure the correct application of the quality systems on the field and to define improvement plan as required. – Process the backlog in release, investigations, and archives. – Challenge the new spare parts creations. – Review the modification proposed by the technical teams (MO). – Quickly understand the regulatory requirements for the spare parts – Use a risk-based approach for problem solving and prioritization of tasks – Blow a quality and compliance mindset through the operational team – Develop and continuously improve expertise linked to spare parts – expert on the field, technical and regulatory watch over, linked with global and corporate expertise functions.
Skills and Knowledge requirements – University degree (Biotechnology, Agronomy, Chemistry or Pharmacy) – At least 5 years professional experience in pharmaceutical environment. – Very good interpersonal relationship skills – To be a good team player to success in each validation project. – Fluent in French, good oral and written communication skills in English – Problem solving and achievement oriented – Knowledge of GMP Regulated environment – Strong organizational skills
Our offer Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and access to training in both technical and non-technical skills. We'll be your career partner every step of the way. Are you interested in this position? We invite you to apply. Do you have any questions? Please contact Aylin Ugurlu at [email protected]
Projets de revamping/modernisation d’équipements de packaging de vaccins
Projets d’installation de nouveaux équipements de packaging de vaccins
Tâches :
Etude préliminaire (layout, chemin d’introduction de l’équipement, impacts sur les machines amont/aval, impact validation, …)
Rédaction d’un URS afin de faire valider le projet/l’équipement au sein de la société et de permettre un appel d’offres vers différents fournisseurs présélectionnés
Organisation de la phase d’appel d’offres
Suivi des fournisseurs pendant les phases de préparation/préfabrication (technique et planning)
Si nouvel équipement : réception de l’équipement et de la documentation chez le fournisseur (FAT)
Analyse des besoins en termes d’alimentations électrique et pneumatique, connexion au réseau data
Organisation de ces connexions (fournir les data et propositions d’implantation au service électrique qui rédige les notes de calcul)
Gestion des master data SAP (nouvel équipement, suppression équipement, master data process control, …)
Participation à l’établissement des différents plannings (projet et microplanning) gérés par le PM
Définition et commande des équipements auxiliaires (convoyeurs, …)
Préparation de la validation
Gestion sécurité et technique du fournisseur durant la réalisation des travaux
Maitrise technique des modifications / du nouvel équipement via le suivi du commissioning
Tests de commissioning
Réalisation et documentation des tests IQOQ
Support utilisateurs et maintenance pour mise à jour de leurs documents
Formation des utilisateurs et maintenance (ou gestion de la formation si donnée par le fournisseur)
Transfert de la documentation technique vers maintenance
Suivi punchlist et Handovers
Gestion des CAPA et déviation associées au projet
Votre profil ?
Minimum 10 années d'expérience dans la gestion de projets techniques de packaging dans le secteur pharmaceutique
Maitrise de l'anglais et du français (parlé et écrit)
Compétence de base en automation
Accréditation BA5
Affinité avec la rédaction de documents de validation
Maitrise de MS Word et MS Excell
Compétences de base Techshare et SAP
Excellente capacité de communication et esprit de synthèse
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 !
En tant qu'Analyste en Validation des Méthodes Analytiques Physico (PM AMR), vous jouerez un rôle crucial dans le département de remédiation des méthodes analytiques. Vous serez responsable de l'optimisation des méthodes analytiques existantes, en mettant particulièrement l'accent sur les techniques telles que les immuno-essais et ELISA, avec pour objectif de réduire l'utilisation de tests sur animaux au profit de tests sur cellules.
Responsabilités :
Connaissance des Méthodes Analytiques : Posséder une expertise approfondie dans les méthodes analytiques, avec une attention particulière portée aux techniques d'immuno-essais et ELISA.
Amélioration des Techniques de Laboratoire : Travailler activement sur le développement et l'amélioration des techniques de laboratoire, en mettant en œuvre des solutions innovantes pour réduire la dépendance aux tests sur animaux.
Suivi des Manipulations : Assurer un suivi rigoureux des manipulations de laboratoire, en garantissant la précision des procédures et en documentant les étapes de manière détaillée.
Analyse des Manipulations : Effectuer des analyses approfondies des manipulations effectuées, identifiant les opportunités d'amélioration et s'assurant de la conformité aux normes de qualité.
Gestion de Projet : Prendre en charge l'intégralité de projets, de leur conception à leur mise en œuvre, en assurant une gestion efficace des ressources et des délais.
Profil Recherché :
Ph.D. : De préférence, avoir un doctorat en sciences avec une spécialisation en méthodes analytiques ou domaine connexe.
Expérience en ELISA et Immuno-essais : Une expérience préalable significative dans les techniques d'ELISA et d'immuno-essais est essentielle.
Compétences en Gestion de Projet : Capable de gérer des projets de manière autonome, avec une attention particulière à la planification et à l'exécution.
Langues : Maîtrise de l'anglais requis pour une communication efficace au sein de l'équipe et des collaborations externes.
Département Remédiation de Méthode Analytique : Compréhension des enjeux liés à la remédiation des méthodes analytiques et volonté de contribuer à des projets innovants.
Adaptabilité et Créativité : Capacité à s'adapter à un environnement dynamique et à proposer des solutions créatives pour améliorer les méthodes existantes.
Si vous êtes passionné(e) par l'innovation et que vous souhaitez contribuer à un projet stimulant au sein d'une entreprise de renommée mondiale, postulez dès aujourd'hui à notre offre. Jefferson Wells s’engage à vous offrir un contrat en consultance, un accompagnement rapproché ainsi qu’un salaire et un package attractifs. Des questions ? Vous souhaitez soumettre votre candidature ? Envoyez un mail à [email protected] .
The QA Validation is part of the QA Operations for one MPU. The QA Validation ensures the QA oversight of the continuous validation activities for one vaccine bulk production unit. Mains objectives of this function are:
To take part in the establishment, the implementation, the follow-up, and the maintenance of the continuous validation plan (CVP)
To define the validation strategies through the change control process (change control & MO notification) – Remark: No signature as task approver/stakeholders.
To write and implement some validation documentation (VP, VSR)
To review and approve specific qualification and validation documentation (IQ, OQ, PQ, Risk Assessment, Periodic validation review – Remark: No signature as final approver for equipment with high criticality.
To ensure the correct application of the validation quality systems on the field and to define improvement plan as required.
To support the production & technical services teams in the implementation of the validation activities
Your responsibilities The QA Primary Validation objective implies the following commitments:
To ensure an efficient and compliant CVP implementation
To provide a compliance and business expertise for some specific technical subjects
The responsibilities of the QA Primary Validation are among others:
Challenge, review and approve qualification and validation (IQ, OQ, PQ, equivalence certificate, requalification protocol/report) documentation and ensure they are written in accordance with the Vaccines standards and procedures.
Write some validation (VP, PQ, VSR)
Review & approve (not as final approver) Periodic Validation Review documentation according to the Bio standards and procedures.
Ensure timely escalation to Management of critical issues during validation and/or project.
Pro-actively identify potential quality and compliance risks and be pro-active in escalation.
Attend all project meetings as QA expert from a compliance point of view the MPU Product & Process, Production and QA Operations for validation topics.
Skills and knowledge requirements The QA Primary Validation must be able to:
Quickly understand the characteristics and the mechanism of a broad range of production equipment and process including their potential impact on product and patient safety.
Use a risk-based approach for problem solving and prioritization of tasks.
Blow a quality and compliance mindset through the validation activities.
Our offer Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and access to training in both technical and non-technical skills. We'll be your career partner every step of the way. Are you interested in this position? We invite you to apply. Do you have any questions? Please contact Aylin Ugurlu at [email protected]
Distribution Planning SPOC is accountable of distribution plans for a group of distribution area:
Will support the manager in order to share experience in the team.
Will be the technical support to standardize the process as much as possible.
Will be part of the continuous improvement in Vx Distribution Planning and Distribution Excellence projects.
Will actively support the team to improve KPIs (examples; weekly plan adherence, reduction of cancellation costs,).
Will be the point of contact for Transversal topics within the Regions (examples; escalations, deviations, …)
Distribution Planning SPOC is responsible for:
working on scenarios to optimize the shipment plan.
Ensure that planning rules are respected (ex: frozen horizon, QA LT) identify risks/issues, propose mitigation plans and escalates issued when needed.
The job is a global role across several countries / distribution areas, with the purpose to:
Support continuous improvement program.
Contribute to RDC performance management and objective achievements.
Manage VDP stakeholders as Customer Service, QA, VDO to achieve common objectives.
Your responsibilities
Order/requirements processing:
Plan, monitor and optimize the forecasted commercial and non-commercial shipments according to the open customer orders.
Customer orders handling in quantities, quality and costs in the requested times and according to procedures, national and international laws and/or rules for commercial and no commercial deliveries
Invoicing/Shipping:
Coordinates the shipments of the products to the subcontractors, in collaboration with the relevant services
Responsible for returns, letter of credits and other shipping documents.
Provide consignee and customs broker with shipping information and documents and follow up until delivery execution.
Performance and administrative management:
Proposes logistics and planning tactics to reduce costs and improve service level.
Supports internal and external audits for the Department and the RDC related to VDP activities.
Planning Specialist:
Be deputy of Vx Distribution Planning Manager.
Be responsible for additional freight costs monitoring.
Ensure using the adequate reporting tools available to monitor their performance and do data analysis.
Interactions and communication:
Support and manage direct relations with VDCC, QA, Finance and Customer Service, LOC’s, RDC’s.
Support others Vaccines Distribution & Cold Chain functions for projects and business requirements.
Skills and knowledge requirements
Master Degree
More than 5 years of experience in supply chain management/Logistics
Strong analytical skills (data gathering and data analysis).
Customer Focus.
E2E view and approach.
Strong influencing skills (developing level).
Ability to work in a matrix / transversal organization.
Ability to simplify complex processes (problem solving).
Effective communication skills, including presentation skills.
Very good knowledge of ERP systems with SAP (R/3 and APO SNP, other simulation tools).
Sense of urgency, flexibility, and accountability.
Enterprise thinking (end-to-end supply orientation, cross functional team spirit, sharing of good practices within the network).
Proven Planning & Organizational skills.
Ability to lead and drive change.
Very good written and spoken English.
Digital knowledge and competencies (proficient level).
GPS basics (proficient level).
Capacity to manage conflicts.
Expertise in Supply chain i.e. Executive Master in Supply Chain Management, APICS certification, Orange Belt certification..
Our offer Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and access to training in both technical and non-technical skills. We'll be your career partner every step of the way. Are you interested in this position? We invite you to apply. Do you have any questions? Please contact me
Our client is seeking an experienced Project Manager who will play a key part in leading Analytical Method Robustness program. The responsibilities will be coordinating the AMR program, including the Control Tower (agenda, meetings, and minutes), and follow up of the different projects included in the AMR plan. This role will consist of identifying method performance issues based on sites and stakeholder inputs, CMV red flags and CPV issues impacted by QC methods. The PM will also have to coordinate any working group for method issues response.
The PM will be responsible for overseeing project timelines, managing resources efficiently, and enhance project delivery.
Key Responsibilities
• Process Improvement: o Continuously assess the effectiveness approach within the AMR program and identify areas for process improvement. o Implement improvements and adjust practices as needed to optimize delivery. • Facilitation and proactiveness: o Help to proactively identify in time method performance issues o Facilitate working group discussion o DMAIC execution follow up • Change Management: o Help manage and communicate changes effectively within the AMR program and across the organization, addressing resistance to change when necessary. • Cross-Functional Collaboration: o Encourage collaboration and information sharing among cross-functional teams involved in the AMR program. o Promote a culture of continuous improvement and learning across teams. • Risk Management: o Identify and manage risks proactively specific to the AMR program. • Stakeholder Engagement: o Communicate in time with stakeholders o Capture inputs regarding to method performance issue impacting the business • Metrics and Reporting: o Establish and maintain relevant metrics and key performance indicators (KPIs) to measure the progress and effectiveness of the AMR program o Generate reports and dashboards that provide transparency into the program's performance. • Adaptability: o Be flexible and adaptable to changing circumstances, adjusting the hybrid approach and practices as necessary to meet the AMV program's evolving needs. • Value Delivery: o Focus on delivering value to the organization by prioritizing work that aligns with business objectives and customer needs.
Skills and knowledge requirements
• Bachelor’s degree in management areas • Minimum 5 years’ experience in project management in a hybrid environment • Demonstrates competency in project management software and methods • Successful experience in people 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
Our offer Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and access to training in both technical and non-technical skills. We'll be your career partner every step of the way. Are you interested in this position? We invite you to apply. Do you have any questions? Please contact Aylin Ugurlu at [email protected]
About our client Our client is looking for Visual Inspection Scheduling
Your responsibilities
Production Planning :
Establish a weekly production schedule by integrating input and production requirements.
Evaluate personnel and production line capacities to carry out mirages.
Utilize SAP (APO-GAND) to model planning activities.
Governance Participation :
Act as the primary point of contact (SPOC) for communication between production and various supply chain departments (internal, filling, packaging).
KPI Management :
Participate in 3 to 4 meetings per week to report production forecasts and achievements.
Team Integration:
Collaborate with a team of 3 individuals to ensure effective coordination of planning activities.
Skills and knowledge requirements
Seniority: Mid-level/senior with previous experience in planning within a GMP environment.
Technical Skills: Strong proficiency in SAP Gand APO.
Languages: Ability to comprehend and read English via emails, but no oral interaction in English required.
Experience: Prior experience in GMP planning is highly desired.
Soft Skills: Proactivity, ability to collaborate effectively with other team members, sense of urgency.
Our offer Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and access to training in both technical and non-technical skills. We'll be your career partner every step of the way. Are you interested in this position? We invite you to apply. Do you have any questions? Please contact me
