Your responsibilities: Support the Quality SPOC for selected contractors / suppliers (in transfer or in commercial operations) for:
Ensuring that Quality systems are in place/in use, routinely monitored and assessed
Mastering quality agreement content
Releasing validation and/or commercial batches, including production and Quality control documentation, within the time frame defined by submission or Market needs and in compliance with regulatory files, good manufacturing practices and regulatory requirements, certify release process and evaluate regularly the certification status
Ensuring all quality activities linked to the contractor / supplier management (deviations, CAPA closure, change control, risks management, complaints, product quality review, …)
Ensuring and maintain good relationships with the contractor in order to guarantee win-win collaboration, through informal meetings and governance meetings.
Representing the QA External Manufacturing within various governance meetings and timely escalate issues to Manager if required by internal process
Identifying risks associated to the specific activities of the CMO
Driving continuous improvement projects with CMO and with internal and external stakeholders (Operations, Technical group, etc.) in order to strengthen the manufacturing activities
Your profile:
University Scientific background (Pharmacist, Phd in life sciences, Bio Engineer …).
Min. 5 years of experience in Pharmaceutical Industry associate with a GMP background
Experience as in QA or production department, with expertise on the field, in quality systems or release. SAP experience is mandatory (deviation, CC, CAPA, …).
Good knowledge of the pharmaceutical current best practice in analytical and manufacturing technologies, validation and GMP compliance
Fluent in English and French
Excellent communication (including presentation) and influencing skills.
Stakeholders’ management: ability to interact with internal & external stakeholders
Ability to travel to CMO (less than 1x/2month)
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]
En tant que Gatekeeper, vous assurez la qualité et la validité des demandes de travail, les planifiez ensuite en accord avec la production et les équipes de maintenance afin de réduire les temps d'arrêts planifiés et en augmentant l'efficacité de la main d'œuvre.
Vos responsabilités :
Vous collectez toutes les demandes de travail, et faites un suivi et un retour aux demandeurs ;
Vous évaluez la validité des demandes de travail, leur pertinence, et leur niveau de détail adapté ;
Vous êtes le garant du Backlog des avis, et de l’absence de doublons dans les systèmes ;
Vous préparez le planning court terme (1-4 semaines) avec une granularité à la pause / shift, pour tous les type d’activités ;
Vous animez la réunion de planification hebdomadaire avec la production ;
Vous planifiez les ordres de travail, y compris la préparation et le suivi de planification mensuelle et hebdomadaire ;
Vous conciliez le planning de maintenance avec le planning de production afin que les différentes activités soient totalement alignées.
Pourquoi vous ?
Qualifications requises :
Vous possédez un bachelier technique ou expérience équivalente ;
Vous possédez des connaissances des outils informatiques Excel, PowerPoint, Word, SAP ;
Vous possédez de minimum 5 ans d’expérience pertinente dans un environnement pharmaceutique.
Horaire de jour (flottant).
Qualifications souhaitées :
Vous êtes ouvert aux nouvelles idées, montrez un intérêt pour élargir vos connaissances, accompagnez le changement, proposez des améliorations en vue d’améliorer la performance ;
Vous vous organisez de façon autonome en fonction des priorités journalières, démontrez spontanément un souci d’ordre et de rigueur. Vous confirmez la planification des ordres de travail avec le client interne et la maintenance ;
Vous faites preuve d’esprit d’observation, vous signalez les anomalies, démontrez la compréhension du process en place.
Si vous avez besoin d’assistance ou d’aménagements particuliers, soit pour participer au processus de recrutement, soit pour vous permettre d’exercer votre travail, nous vous remercions de nous en informer de manière à ce que nous puissions prendre les mesures adéquates.
Notre Offre 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]
In coordination with Engineering Office and Project Management, ensure correct design, construction, commissioning and qualification in full compliance with internal requirements and authorities' requirement of Secondary equipments and Aseptic technologies package.
Related to these packages, it includes :
Being company's representative for all Secondary equipments-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 punchlist solving
Writing and executing commissioning and qualification protocols/reports
Provide projects support in terms of technical expertise, contractors’ management and troubleshooting capabilities.
Facilitating handover process towards the end user
Profile:
Education :
Engineering degree with 7 years experience as Process Engieer in Secondary Equipments, oriented Aspetic filling lines and Freeze-dried technologies, domains.
Strong Experience in the Pharmaceutical industry and cGMP environment.
BA4 BT electrical certification granted by Employer
Hard skills
French / English
Demonstrates deep knowledge and expertise in design, implementation and qualification of engineering projects
Demonstrates deep knowledge and expertise in design, implementation and qualification of engineering projects.
Definition of functional, technical and quality requirements.
Realisation of reviews of process studies, P&ID’s and layouts
Oversight contractor's performance.
Integration of operability and EHS requirements at all design steps.
Preparation of the project testing, commisioning and inspection requirements
Organize legal conformity visits
On-site verification of execution according to good practices
Coordination with suppliers representatives, MPU representatives (User, QA, Validation, Maintenance,…),..
Soft Skills
Team working & Communication / Autonomy / Contractors' management.
Good project integration experience: organisation, schedule, qualification, validation, technologies.
Experience in the Pharmaceutical industry
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.
The process vision engineer will be a skilled professional that will work within the vision team, along with the other vision experts. In this position, he or she will be responsible to maintain and improve the automated visual inspection program as well as the robustness of other vision systems.
As a technical expert, he (or she) will also have to build and to manage technological knowledge for Automated Visual Inspection linked to manufacturing processes into the Production unit for syringes and/or vials. He (or she) will:
Assure proper functioning of Automatic Visual Inspection Machines in the Production unit.
Fine tune / develop new or existing vision programs to decrease false rejects or to improve detection capabilities.
Interact with production, Quality and global vision experts.
Lead and/or participate to technical investigations in case of atypical false rejects rate with the vision team, production supervision, Quality and maintenance team.
Provide vision expertise to support maintenance activities.
Develop technical knowledge in AVI with the support of local and global experts and supplier and supports field technicians as well as production performance.
Participate to the continuous improvement process performance (simplifies processes, design a short and mid-term strategy for the programable contents, lowers the false ejection rates)
Lead investigations and trials related to process improvement for vision (on the AVI machines and on the upstream process). Propose (and integrate) solutions for improvement.
Respects current Good Manufacturing Practices (CGMP) as well as GMP procedures.
Provides technical support to the deviation handling process (root causes identification and of CAPAs task execution in order to avoid recurrence of deviation with technical root causes).
Skills and Knowledge Requirements
Education : Industrial engineer (or similar level of education)
Knowledge : Automatic visual inspection, Vision systems (not necessarily linked to pharma), automated system programming.
Language : English and French.
Experience : 3-5 years' experiencein a similar function
Able to work in team in a production environment
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.
Réalisation des expériences de laboratoire définies avec le responsable de projet
Manipulations en laboratoire afin de reproduire à petite échelle les étapes secondaire de production de nos vaccins : Media Preparation – Formulation – Filtration – Filling –Lyophilization en utilisant les techniques tel que : pH, Conductivité, Osmolarité, Viscosité, Turbiscan (vitesse de sedimentation), Néphélométrie, SLS et/ou DSL, Occhio, FTU units
Interprétation de la signification de ses résultats de manière assistée et conclusion scientifique
Rédaction d’un cahier de laboratoire de manière autonome et en respectant les procédures en place
Gestion du planning de vos manipulations
Parlons de vous !
Vous êtes en possession d’un Bachelier à orientation scientifique (Chimie, Biochimie, Biologie, …) ou d’un A2 (CESS) avec une expérience probante
Vous avez idéalement une première expérience en laboratoire dans un environnement pharmaceutique ou associé et vous avez les bases pour pouvoir manipuler sous flux laminare
Rigoureux(se), précis(e) dans vos tâches, vous avez l’esprit analytique et un bon sens critique
Vous savez travailler en équipe, êtes ouvert(e) au changement et à l’innovation.
Ce que nous pouvons vous offrir ?
Jefferson Wells te propose un contrat permanent en tant que consultant avec un package salarial attractif et te donne accès à des formations techniques et en compétences interpersonnelles. Nous serons ton partenaire de carrière à chaque étape du parcours.
