Our partner is looking for a QA Validation to join its team. You will provide QA support and oversight to validation and manufacturing activities according to validation and production procedures. This international company is well-known for its pharmaceuticals and vaccines.
Your responsibilities?
As QA Validation, you will Provide QA support and oversight to validation activities according to validation procedures.
Review/Approve the validation documentation regarding the GMP requirements and the procedures
Ensure that production practices are aligned with validation conclusion
Attend all project meetings as QA validation representative
Ensure timely escalation to Management of critical issues during validation
Contribute to the deviation process providing QA oversight and approving deviation for deviations related to validation activities and/or impact of manufacturing deviations to validation activities
Pro-actively identify potential quality and compliance risks and manage these risks through the risk register and quality plan process
Work in autonomy with supervision/coaching
To define the validation strategies through the change control process
To write and implement some validation documentation (Validation Plan, Validation Summary Report, Risk Assessment, Gap Analysis, Periodic review ….)
To ensure the correct application of the validation quality systems in the field and to define improvement plan as required
To support the production, QA and technical service teams in the implementation of the validation activities.
Your profile?
Engineering or scientific background (or equivalent acquired through professional experience)
Former relevant industrial experience related to the requested seniority in Validation and QA in a biopharmaceutical industry.
Knowledge of GMP / CFR / Eudralex …
Knowledge of different regulations and standards related to validation activities
Good communicator, autonomous and rigorous
Team player
Critical mind and quality oriented
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]
Our partner is looking for an EHS support to join its team. This international company is well-known for its pharmaceuticals and vaccines. Your responsibilities? Your responsibilities are to participate in the coordination of subjects EHS for two revamping and one extension projects implementation/modification of various equipment’s (clean utilities, black utilities, process equipment’s, etc.); the initiation, planification, implementation, monitoring and closure of EHS subjects for CAPEX projects, act as a key interlocutor in his/her discipline between the unit production and other services.
Provides support to the TS representative for CAPEX projects.
Monitors the implementation of EHS subjects for CAPEX project to ensure that the installations comply with the guidelines in place and good practices.
Provides EHS input in various fields (mechanical, electrical, design, etc.)
Plans and coordinates activities related to CAPEX projects and/or the correction of identified gaps.
Participate in the meetings necessary to monitor the project.
Ensures monitoring of field activities through the coordination of work permits.
Play the role of work RP (responsible permit) for permit to work.
PTW preparation
Development of operating methods
Collection of EHS feedback from maintenance technicians
Help with monitoring dangerous situations
Provide support for risk analyzes
Carry out field visits
Your profile?
Master’s degree in engineering in one of following activity field (mechanical, automation, electromechanical, chemistry…) or equivalent by experience.
Prevention advisor is an asset.
Experience in CAPEX project in EHS role.
Has already participated in the closing of a project and the handover process.
Experience in a pharmaceutical company (GMP environment).
Minimum 3 years’ experience in project environment
Knowledge of the vaccine manufacturing environment.
English (Technical English is a minimum)
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. Do you have any questions? You can contact Anaïs Malikian, [email protected]
La personne en charge assurera le support Qualité des équipements de laboratoires Vx CL&AP (Clinical Lab & Assay Portfolio) and HBSMCT (Human Biological Sample Management Central Team) au sein du nouveau Bâtiment Rx-86.
Les Responsabilités
Assure le suivi QA des demandes liées aux équipements de laboratoire dont l’approbation des documents relatifs à :
La validation, qualification/requalification des équipements en alignement avec les requis décrits dans les procédures.
Plans Calibrage & Mesure / Plan de maintenance des équipements en alignement avec les requis décrits dans les procédures.
Revoit et approuve les Déviations / Non-conformités ainsi que les CAPAs associés liés aux équipements de laboratoire en appliquant les requis décrits dans les procédures.
Identifie les risques et opportunités qualité et les escalade de manière appropriée.
Est le représentant Qualité dans des meetings multidisciplinaires et gouvernance projet.
Connaissances et Expériences resquises
Diplôme universitaire dans le domaine scientifique (biologie, chimie,…).
Expérience dans Analytical Equipment and IT Validation est un plus.
Expérience dans la Deviation & CAPA Management est un plus.
Connaissances dans le Analytical Biological Testing est un plus.
Expérience avec AP / LEM / Binocs est un plus.
Minimum 5 ans d’expérience.
Notre Offre 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] .
Our partner is looking for a Product coordinator support to join its team. This international company is well-known for its pharmaceuticals and vaccines.
Your responsibilities?
Write and ensure delivery of approved stability protocols and reports, compile and/or double check stability data
Assemble the necessary data and information to issue the annual Product Quality Review for specific vaccines
Write and edit QC change control
Compile data in comprehensive power point presentations
Gather necessary information to complete product impact assessment in deviations were QC coordination is involved
Your profile?
Master or PhD Scientific university degree (Engineer in Chemistry, biochemistry, or Pharmacist,…)
Working in cGMP environment
Analytical methods on biopharmaceuticals
SAP knowledge is a plus
Knowledge of change control processes
Documentation and scientific rigor
Writing skills in 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.
Pour notre client spécialisé dans le secteur bio-pharmaceutique, nous sommes à la recherche d'un Dessinateur Tuyauterie. Le but est de concevoir de nouvelles solutions en traitement de l'air pour des clients en Pharma et Biopharmaceutique.
Quelles sont vos responsabilités ?
Conception de pièces techniques (en inox…) pour le pharmaceutique
Proposition de solutions techniques
Préparation des documents de production
Rédaction de la documentation technique en collaboration avec les opérateurs de production
Participation aux activités du département qualité
Qui êtes-vous ?
Dessinateur technique en électromécanique, mécanique, ou équivalent
Expérience dans la conception de tuyauterie
Maîtrise de SolidWorks
Connaissance des environnements mécaniques-techniques avec exigences de qualité basées sur l’ISO9001
Capacité d’intégration/travail en équipe/communication
Maîtrise des outils bureautiques
Connaissance des langues : français et anglais
Que pouvez-vous espérer ?
Jefferson Wells vous offre plus qu'un emploi ou une carrière mais surtout l'opportunité de travailler sur des projets attractifs. C'est l'opportunité de participer au monde de demain ! Vous aurez l'occasion de toucher aux aspects très concrets, très techniques des projets mais aussi l'opportunité d'être créatif et de proposer des solutions innovantes !
Voulez-vous relever le défi ? Alors n'hésitez pas à postuler !
Analyse and approve the master data’s requests (change requests on maintenance plans or spare parts/drawings,…)
Launch the investigations if necessary/share the feedback if necessary
Realise QA oversights (documentation/shopfloor)
Collect investigations data and analyse them in order to prepare a final investigation report (top chrono, check of the investigation )
Approve the maintenance work orders requests (ie.: technical modification requests) and participate to the meeting in link
Your profile ?
Navigation in SAP
GMP competencies
Risk based approach
Quality mindset.
Good interpersonal relationship skills
Good communication skills.
Good analytical skills; ability to investigate and ask questions, on the shopfloor.
Autonomous, Rigorous, Structured, Systematic.
Ability to work in team
University degree in Sciences (Bio Engineer, Biologist, Chemist,…)
SAP, good knowledge of outlook tools
Fluent in French, spoken and written; English 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 kindly invite you to apply. Do you have any questions? You can contact Caroline, [email protected]
Pour notre client spécialisé dans la production d'injectable dans le milleu bio-pharmaceutique, nous sommes à la recherche d'un ingénieur de projet mécanique. En tant qu'ingénieur de projet, vous suivez différents chantiers de l’entreprise (conception, production, installation).
Votre mission
Suivi des chantiers de production et d’installation d’équipements
Gestion et entretien des contacts techniques et commerciales chez les clients
Rédaction des dossiers techniques des projets
Préparation des documents de production
Rédaction de la documentation technique en collaboration avec les Opérateurs de Production
Participation aux activités du Département Qualité : suivi des calibrations des instruments, des maintenances d’équipement, mise en place d’outils de gestion, etc.
Suivi de production
Contrôle Qualité des pièces produites
Contrôle Qualité des documents de production
Votre profil
Bachelier en Electromécanique, Mécanique ou Industriel
Expérience dans le secteur Bio-Pharmaceutique (production ou bureau d’étude)
Connaissance des environnements mécaniques-techniques avec exigences de qualité basées sur l’ISO9001
Expérience en people management
Capacité d’intégration/travail en équipe/communication
Maîtrise des outils bureautiques
Connaissance du français et de l'anglais
Notre offre Jefferson Wells vous offre plus qu'un emploi ou une carrière mais surtout l'opportunité de travailler sur des projets attractifs. C'est l'opportunité de participer au monde de demain ! Vous aurez l'occasion de toucher aux aspects très concrets, très techniques des projets mais aussi l'opportunité d'être créatif et de proposer des solutions innovantes !
Voulez-vous relever le défi ? Alors n'hésitez pas à postuler !
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.
Review/Approve the validation documentation regarding the GMP requirements and the GSK Vaccines procedures
Ensure that production practice are aligned with validation conclusion
Attend all project meetings as QA validation representative
Ensure timely escalation to Management of critical issues during validation
Contribute to the deviation process providing QA oversight and approving deviation for deviations related to validation activities and/or impact of manufacturing deviations to validation activities
Pro-actively identify potential quality and compliance risks and manage these risks through the risk register and quality plan process
Work in autonomy with GSK supervision/coaching
To define the validation strategies through the change control process
To write and implement some validation documentation (Validation Plan, Validation Summary Report, Risk Assessment, Gap Analysis , Periodic review ….)
To ensure the correct application of the validation quality systems in the field and to define improvement plan as required
To support the production, QA and technical service teams in the implementation of the validation activities.
The skills and Knowledge Requirements
Former relevant industrial experience related to the requested seniority in Validation and QA in a biopharmaceutical industry.
Knowledge of GMP / CFR / Eudralex …
Knowledge of different regulations and GSK standards related to validation activities (VP, VSR, IOQ, VSR, PVR)
Knowledge of packaging activities
Knowledge of KNEAT (electronical validation system), MADB (Alarm management database), SAP
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.
