Notre partenaire est actuellement à la recherche d'un Document Manager pour rejoindre son équipe. Cette société internationale est réputée pour ses produits pharmaceutiques.
Vos responsabilités ?
Gestion de la création et mise à jour documentaire
Planification et suivi des sessions de formations
Point de contact pour toute les questions liées à la documentation et formation pour le projet new wade et dispatch vers la personne adéquate
Suivi et communication des décisions opérationnelles avec le partenaire externe
Etroite collaboration avec l’équipe documentation, formation et opérationnelle Warehouse
Participation aux réunions de suivi projet
Mise en place et suivi de KPI pour la documentation et la formation projet new wade
Change control : responsable de tâche
Gestion de déviations en tant que deviation team et responsable de taches CAPA
Ton profil ?
Maitrise des outils informatiques, microsoft et SAP (ERP)
Agile et flexible pour s’adapter aux différentes demandes
Des connaissances en warehousing sont un atout majeur
Compétences professionnelles completes en anglais (interactions et échanges avec les parties prenantes du projet en anglais)
Capacité d’organisation et de suivi de plusieurs points en parallèle
Personne de terrain et pragmatique car il faudra être pertinent dans les modifications documentaires et l’organisation des formations
Notre offre ?
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 dans les domaines techniques et des compétences non techniques. Nous serons votre partenaire de carrière à chaque étape de votre parcours.
Our renowned client from the pharmaceutical industry is looking for a Third Party Expert to complete their team.
What are your responsibilities?
Be accountable for technical management including risk management, deviation management, change control management, Product Technical Specification (PTS) and knowledge management. Participate to operational meetings with CMO.
Drive continuous improvement projects with his/her CMO and with internal and external stakeholders in order to strengthen the CMO operational/quality activities. Support continuous improvement for complex/transversal projects.
Give support to the QA team to ensure compliance of the EMV operations with cGMP and Authorities requirements.
Timely escalate issues to Manager if required by internal process
Be accountable for reporting (KPI, monthly)
Let's talk about you !
Fluent in French & in English
Good communication skills
Well organized
What we offer you ?
Jefferson Wells offers you a permanent contract as a consultant with an attractive salary package and will give you access to training in technical matters and soft skills. We will be your career partner every step of the way.
Are you interested in this offer? We invite you to apply. If you have any questions, please contact Marie Rossenfosse : [email protected]
Our partner is looking for a Third Party Expert to support their team. This international company is well known for the research, the development, and the commercialization of its pharmaceutical products.
What are your responsibilities?
You will support the Supplier Relationship Manager (SRM) who is accountable for managing the relationship for one or several CMO’s. Here are your main responsibilities:
Be accountable for technical management including risk management, deviation ownership, change control authoring and coordinating, Product Technical Specification (PTS) and Method of Production (MOP) review and knowledge management.
Participate to CC Implementation committee.
Drive continuous improvement projects with your CMO and with internal and external stakeholders in order to strengthen the CMO operational activities.
Support continuous improvement for complex/transversal projects.
Give support to the QA team to ensure compliance of the EMV operations with cGMP and Authorities requirements.
Timely escalate issues to Manager if required by internal process
Be accountable for reporting (KPI, monthly)
Be the backup of the SRM
Who are you?
You hold a scientific degree
You are flexible with ability to adapt to changing scope & priorities
You are able to lead and manage cross-functional projects
You are Autonomous and results-driven
You are fluent in French and English
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.
Our partner is looking for a Customer Service Coordinator to support their team. This international company is well known for the research, the development, and the commercialization of its pharmaceutical products.
What are your responsibilities?
You will manage order fulfilment for customers. Here are your main responsibilities:
Manage the order book for multiple countries or markets (both for private as for public markets) on a 22 weeks horizon
Create sales orders in SAP for the delivery of final products, final container products or bulk to customers worldwide
Drive the customer order book analysis for blocking points or important delays versus the first date to ensure on time delivery; Escalate blocking points or delays to the Supply Coordination Manager(s) for resolution (as they need to coordinate with MPUs, RA, QA, VDP, CMO, …)
Analyze and comment SCIM events in terms of Supply issues and actions to be taken to mitigate any market impact
Ensure actions required for WBR or requested by the Regional Supply Coordination Manager are completed on time, this might cover STO creation, COD/IMT, UTL documents, AP4 statements, …
Only for Supra scope: stock analysis of P050 batches and final pack inventory management; Escalate P050 inventory shortage and short shelf-life inventories
Analyze and comment the root cause of finished goods batches produced and not allocated (for MTO products)
Ensure that all RA requirements, compliance rules and GMP regulations are respected when applicable
Ad hoc contact with officers in VDP, MPU, NPI, … might be required to obtain operational information
Potential involvement in continuous improvement projects when required
Who are you?
You hold a bachelor’s degree
You have at least 2 years ‘experience in Supply Chain (customer service, planning, production,…)
Experience in a pharmaceutical industry is a plus
You speak English (French is a plus)
You are proactive, rigorous and organized
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.
Our partner is looking for a Project Manager to reinforce its team. This international company is well-known for its research, development, and marketing of pharmaceutical and vaccines
What are your responsibilities?
The team is responsible to ensure all CAPEX projects are delivered within budget & schedule according to plan with Quality standards & Safety as a priority. Our customer and stakeholder satisfaction are part of our main focus. The team is accountable for the adherence to our partner’s engineering standards and practices in the projects. Here are your main responsibilities:
You are accountable for the successful delivery of the Automation CAPEX projects for Belgium Operations according to the PMF (Project Management Framework) procedures
You are responsible for the safety KPIs of your project and the integration of all EHS related requirements.
From the very start of the project, you are responsible for the set-up of the project organization and will remain responsible from the detail design to Hand-over and Close-out phase to ensure an outcome which meets all the defined project objectives for cost, schedule, quality, safety and environment and delivers the business benefits.
You work with all internal and external stakeholders to have the required project team at your disposal.
You ensure projects are developed with PMF methodology and follow lifecycle of the project.
You are responsible for preparing the projects for our partner’s project governance procedures
You are responsible for the preparation the project for the stage gate reviews at the end of each project phase.
You work closely with Automation technical SME team for the scope development and technical strategy definition of the project.
You work with customers & PMO to prepare/review projects and ensure that they are encoded in the MSP Online.
Drive the Project Execution Plan process, documenting the project delivery strategy and the success criteria according to the PM Standard.
Establish a Quality Plan for the project in a proactive way with all stakeholders.
Prepare monthly progress reports according to the PMF Standard. Keeps the Steering Group and Sponsors informed of critical issues that could jeopardize projects success.
Develop a risk management strategy for the project and implements associated processes and tools to ensure effective identification, monitoring and management of project risk.
Lead the qualification of the engineering services providers, contactors and vendors and decide and direct the appropriate contractual strategy. Uses proven selection processes to develop the appropriate contract strategy for the project, selects and manages contractors and settles any claims in accordance with company policy.
Implement strict project and financial controls, including procedures for change control / management, cost control / forecasting, physical progress / productivity measurement, and invoice review / payment.
Ensure that the overall commissioning, validation & handover strategy fully complies with the PM Standard to ensure a timely and complete handover to the Customer.
You are responsible of all administrative task link to project resources training matrix, invoicing, procurement task, quality (CAPA, deviation), Gemba, SD, work permit, supplier site access…
You ensure suppliers certification to work on our partner’s site
Develop a deep understanding of client’s needs to design/review sustainability strategy offerings tailored to the needs of the clients.
Your partners are QA, MPU technical service (maintenance), Automation, P&P, engineering office, project suppliers.
You are responsible to put in place all needed meetings and governance to support project activity
You have to check that an after-project support or contract support are in place to maintain equipment lifecycle (business as usual in place)
You are accountable and responsible to have the complete oversight of the co-activity between your project and all adjacent projects to be able to construct a mitigation plan which avoids any negative impact on your project
You are responsible to visualize all benefits and impacts relating to all automation topics (OIT, eDI, OSI PI, …) for your project. In this regard, you will work together with the BeEM Automation Manager to assure the project alignment with the Belgium Automation strategy
Who are you?
You hold an Engineering degree or equivalent in Mechanical, Automation, Electrical or Chemical
You have Min. 5 years of CAPEX Project management experience as PM or Program Manager
You have an experience with industrial revamping projects within a shut down in a GMP environment
Experience with Siemens Control systems PCS7 and WinCC
You have knowledge of data base as OSI PI and especially connection to PCS7 is a plus
You have knowledge of specific Automation subjects as Data Management & Data Integrity, Obsolescence management, Cyber Security, process control systems is a plus
You are Logical and well-reasoned approach to solve problem
You are Fluent in French and English
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]
Our partner is looking for a Packaging Validation to join its team. This international company is well-known for its pharmaceuticals.
What's in store for you?
Training on access, site and packaging validation procedures.
Shadowing of the validation team on the P1D3 and N5I1 production lines in order to know the GSK pack environment
Familiarization of the current process and the new process of identification of CPP (Critical Process Parameters) which has just been defined by the Global.
Accompaniment of a CPP validation on the G10D5 line
Implementation of corrective actions related to the current CPP process on the lines.
Organize 4 workshops (one per production unit) in order to implement the new CPP process.
Identify actions for the implementation of the process and write templates.
Writing and execution of the protocols for the implementation of the new process
Execution of the protocols and report for the implementation of the new process
Let's talk about you !
You speak French and English
You have experience in the pharmaceutical industry
You have experience in all aspects of packaging and validation
You are curious, eager to learn and you like teamwork
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 Rossenfosse : [email protected]
Our partner is looking for a QA Documentation Specialist to support their team. This international company is well known for the research, the development, and the commercialization of its pharmaceutical products.
What are your responsibilities?
As a GMP Compliance Officer you will Contribute to the management of our partner’s Global Quality System (Documentation) which is used by all Vaccines sites and throughout the Vaccines business. Here are your responsibilities:
Be able to guide/explain the Global Doc TeamSite (Refer to tuto’s, others Doc managers of MSAT, GENG,…).
Perform Compliance review activities (eg. Review of templates)
Support the global documentation network on creation of new ways of working upon migration to the new documentation system (review, support to design new processes)
Act as custodian of the global Doc communities (grant access, monitor the folders content) and support pre-migration activities (eg. enrichment)
Contribute to the creation of Global Written Standards on Vaccines level (job aid, wikis etc.)
Assess the fit for purpose documentation on an enterprise level and adapt based on Vaccines needs (documentation from GSC/ R&D etc.)
Provide training based on new defined documentation procedures
Who are you?
You hold a Scientific degree
First experience in in a similar position
Good knowledge of GMP and Quality Management System (QMS)
Good knowledge of GxP documentation activities
You are a good team player with communication skills
You are fluent in French and English
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 partner is looking for a Project Manager R&D to support their team. This international company is well known for the research, the development, and the commercialization of its pharmaceutical products.
What are your responsibilities?
As a Project Manager, you will plan and execute several projects in Microbiology Innovation and Modernization Initiative embedded in our partner’s strategy. This includes but is not limited to working with internal and external partners to plan, conduct and evaluate and implement technological solutions for QC Microbiology. Here are your main tasks:
Act as coordinator and project manager innovation projects.
CRO contract negotiation to execute the laboratory work incl. cost management.
Oversight laboratory work and interim progress evaluation (internal and external).
Draft and own study plans for internal approval and CRO approval
Sample organization incl. shipment and potential linked change control for sample management where required
Scientific evaluation of the study results
Conduct complex stakeholder management internally across sites and countries
Draft publication/position papers/guidance documents for the global QC department
Draft abstracts, posters, presentations for external advocacy on Microbiology Innovation.
Perform literature research and summarize in short briefings for scientists and senior management
Ensure documentation, minutes and reports are produced in a timely manner and are shred with major stakeholders and archived in line with the company requirements.
Who are you?
You hold a Scientific degree and have Analytical a background in Microbiology.
First experience in QC testing in GMP environments and/or validation of alternative microbiological methods (e.g. sterility, bioburden, endotoxin testing,…)
You are highly structured and organized with strong PM skills and scientific mindset
You are a good team player with communication skills and a diplomacy approach when dealing with colleagues within or outside the organization (in UK, Germany, Italy, US and Belgium).
You are fluent in English (any other language 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 partner is looking for a Specialist QC Transfer to join its team. This international company is well-known for its pharmaceuticals and vaccines.
What are your responsibilities?
Execute the QC tests transfer activities according to SOP procedure between our partner’s sites in Europe
Draft, assign and support the following documents by co-building it with the experts, major stakeholder and if needed decision bodies; this includes the signature procedure:
Test Transfer Plan (TTP) at the beginning of a project, or when required.
Method Transfer Plans of the test transfer method protocols (via the AMTP/R (analytical method transfer protocol/report) process documentation).
Change request between sending and receiving sites
Use statistical tools and QC tests validation protocols/reports to:
define the tests transfer criteria, in collaboration with QC statisticians, QC coordinators (GQC) and QA colleagues
analyze the QC results obtained locally and write the AMTR (report) documents.
Support the training coordination between donor and receiving sites
Support the transfer strategy in resolving bottlenecks and showstoppers
Draft publication for replacement and reduction of animal testing scientific. Act as key contact for all involved parties related to Data work and review.
Draft abstracts, posters, presentations for external advocacy on the topic of replacement and reduction of animal testing.
Perform conclusive Literature research and summarize in short briefings for Scientists and Senior Leaders
Ensures documentation, minutes and reports are produced in a timely manner and are shred with major stakeholders and archived in line with the Company requirements.
Who are you?
You hold a Scientific master’s degree
You have minimum of 8 years of proven experience in setting up & leading successful method transfers within the pharmaceutical industry
You have Scientific and Analytical background of the “in vitro” and “in vivo” QC analytical methods
You are a good team player with communication skills and a diplomacy approach when dealing with colleagues within or outside the organization
Good written and oral presentation capability in English
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 +32497/51.50.9
The Construction Manager will be responsible for the safe day to day management of the Construction and Demolition works including temporary and enabling activities and provides Construction expertise and input to the Front End engineering stages. He is typically appointed during the scheme design stage and will report to the Project Manager taken into account the selected project execution strategy. The Construction Manager ensures that all Construction and Demolition requirements are properly considered in safety, operability, maintainability, design, cost and schedule aspects of the project.
What are your responsibilities?
To have overall responsibility for monitoring and organizing the construction and demolition activities associated with the Project
To ensure that a comprehensive Construction and Demolition Plan is prepared and updated, which co-ordinates all Project construction and demolition activities
To provide the management resource, as appropriate, throughout the construction and demolition phases to ensure co-ordination of activities and achievement of agreed milestones.
To ensure designers, contractors and other team members are EHS competent and appropriately prequalified
To ensure that the Manager of the Construction (contractors) delivers the project safely in conformance with the local regulations and in compliance with the company requirements
To agree the responsibilities and accountabilities for project construction EHS with the host site EHS Manager
To encourage and support an EHS culture that supports the values of the company
To write the initial Construction Safety Plan (CSP) for briefing the Manager of Construction (contractors)
To ensure all workers receive a host site and project specific construction induction
To ensure that the CSP is regularly reviewed and updated by the Manager of Construction
To implement a process of EHS performance assurance through a programme of audits, observations and interactions
To ensure that the Manager of the Construction (contractors) implements a proactive EHS programme encouraging recognition of the workforce and feedback / engagement with the workforce
To ensure that construction and demolition issues are addressed through all phases of the project life cycle
To ensure that all activities within this responsibility are undertaken on time to allow the smooth progression throughout the Project from Initiation to Handover
To ensure that the project delivers all statutory and regulatory requirements in the construction arena and complies with all relevant company's standards
To influence the design, to ensure that the new or modified plant and/or building is capable of being constructed and maintained in a safe manner
To liaise with the relevant project, corporate and site engineering and technical functions on all construction and demolition aspects of the project.
To ensure that the requirements of the regulations are complied with, including:
Appointment of CTM according to Belgium King’s decree
Construction Health and Safety Plan (before Construction commences) – PGSS
Particular Safety Plans provided by the contractors
Social legislation rules and records are encountered by all project partners on site
Creation and maintenance of the Project Safety File for construction phase
To arrange as necessary for any design reviews and assessments to be undertaken and to participate in them as appropriate, for example: Constructability, Lean Construction.
To ensure that the plant mechanical completion and IQ is completed on time with full documentation.
To ensure a safe system of work is in place prior to construction and demolition activities taking place.
To ensure the Change Control procedure for field variations is in place and strictly adhered to
To ensure construction management resources are adequate
To have overall responsibility of H&S management on the construction phase of the project including waste management
To ensure that a construction and demolition strategy is prepared and kept updated, ensuring all involved Team members and contractors, where appropriate, are aware, agree and understand their responsibilities to minimize the impact on the Site during construction and demolition activities.
To ensure that Construction and Demolition logistics and materials management activities are carried out safely and in line with lean construction methodology
To advise and assist the Project Manager in the approval of construction and demolition invoices and progress states
Set up and chair regular meetings to ensure construction and demolition progress and safety are managed to meet the requirements of the project.
To regularly report to the Project Manager and other Team members on all Contractors’ performance, including progress to schedule, safety and standard of workmanship and advise on time of any potential issues
Will act as GSK representative for all Construction & Safety activities
Help EO to coordinate co-activity with other surrounding projects
Enforce Safe Behaviours / Methods / House keeping
Review/Approve Work/Fire Permits managed by the EO
Ensure all people on site are trained and equipped with adequate PPE
Ensure that all GSK safety requirements are implemented on the site works
SPOC in case of incident/accident – Follow-up of Root Cause Analysis, …
Participate to daily/weekly CM meetings
Ensure CM and construction follow-up on the shopfloor of building works and clean room finishes packages
Ensure equipment/system are properly integrated inside building (constructability)
Ensure, with discipline Engineers, Construction QUALITY for all packages
Coordinate with EO Equipment delivery (routing, planning, cranage, …)
Report CM issues to weekly coordination meeting
Ensure with EO the tracking of construction schedule with all key contractors
Assist EO (with flow charts) for construction planning follow-up, especially about the critical path
Report issues / progress to PM the company
Ensure interface within the Site Master Plan activities (safety, coordination, Access, Parkings, …)
Assist PM and follow-up EO for construction punch lists
Assist PMd and EO for acceptance certificate and associated punch list
Assist on the shopfloor C&Q team for start-up and commissioning activities
Who are you?
Master/bachelor degree in engineering
Experience in a similar function
Pharmaceutical experience is an asset
ICT Skills
SAP
MS Office
PM experience (PM certification is an asset)
Rigor in execution, results driven, analytical skills, pragmatic
Demonstrated ability to influence
Recognized excellent customer focus and interpersonal skills
Demonstrated stakeholder management skills a must
Able to adapt to audience (from blue collars to senior leaders)
Change management basics
Rigor in execution
English Business, French Fluent
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 Rossenfosse: [email protected] or +32494/91.87.40
