‘Global Quality Auditing Outsourcing R&D Lead’ implements a Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) audit strategy, including delivery of a risk-based audit program covering the quality and compliance of the GCP/GLP Quality Systems. The incumbent is by this means ensuring that clinical trials are managed in compliance with regulatory requirements, contractual agreements, as well as company’s Global Quality Management System; and that compliance risks are appropriately identified and mitigated.
The Responsibilities
1. External Auditing vendor management
Support vendor management involved in R&D audit activities and ensure compliance with regulatory requirements.
Play a key role to assist in defining, evaluating, and monitoring key performance indicators (KPis) and drive key quality indicators (KQis) for R&D auditing vendors, and assisting with continuous improvement initiatives relating to management of vendors.
Review and/or approve required Auditing Documents related to the activities in scope.
Prepare, support and follow-up on R&D (GCP and/or GLP) audits performed on behalf of the company by external vendors, as per established process, contracts, and procedures. Ensure that execution of outsourced audits is conducted and completed in alignment with internal audit processes and standards. This also includes the appropriate oversight of vendors performing audits on behalf of the company.
As required, provide management with a summary and analysis of quality risks and outcomes related to Auditing vendors activities.
2. External Auditing:
Contribute and/or participate in the development of the risk based GLP/GCP audit program through evaluation of elements of the internal quality system and their effect on the overall state of compliance of the system.
Perform GCP and/or GLP audits as per annual audit program (investigator sites, vendors, systems, … according to established audit strategy).
Perform GCP and/or GLP audits of potential new vendors/partners for purposes of qualification prior to contractual relationships.
Proactively manage findings, responses and CAPAs arising from audits in the Audit Management Tool, using all reasonable efforts to obtain prompt mitigation of deficiencies by responsible functions/persons and escalating concerns as required to senior management.
Support the preparation, hosting and follow up of critical Regulatory Authority inspections related to clinical activities, in collaboration with the R&D and PV Quality team.
3. Drive Insights for UCB through Data:
Ensure timely and accurate input of audit data in Audit Management Tool.
Contribute data and feedback to GCP/GLP-relevant internal stakeholders in UCB (e.g. Global Clinical Science and Operations, Global Clinical Development, Development Rare Disease, etc.) relating to Key Quality/Performance Indicators and quality compliance status.
4. Compliance Issues:
Through active participation to several forums and through direct interaction with colleagues, escalate concerns and provide expert guidance on GCP/GLP compliance issues to support the development and implementation of necessary CAPAS and quality improvement measures.
Escalate Critical Compliance risks/issues to Global Quality Auditing Leadership.
5. Consulting, Educating, Quality Improvement, and External Focus:
Utilize in-depth knowledge and understanding of current business trends, applicable regulations, and quality principles, to collaborate effectively and influence approaches to quality, and ensure work products and output are aligned with regulatory guidelines, ICH/GCP, GLP regulations, other applicable regulatory requirements, and the company global quality standards.
Participate in medium-long term projects within competence.
Upon the request of/with the approval of Global Quality Auditing Leadership, perform other tasks within competence (as determined by relevant training, experience and/or qualifications).
The Skills and Knowledge Requirements
Substantial and broad-ranging experience in the pharmaceutical/biotechnology area including significant time working in GCP/GLP related areas.
3 years’ experience in leading full range of GCP audits for internal processes/units and external partners or vendors, with depth of understanding of the theory and practice of quality management.
Experience in the pharmaceutical/biotechnology area including time working in GLP and/or GCLP-related areas.
Minimum of 3 years of auditing and 5 years overall dealing with research and development area. Experience in vendor management is a plus.
In-depth knowledge and understanding of ICH-GCP, applicable regulations (domestic and international), quality principles, relevant business processes and techniques. Able to apply theoretical knowledge in practical situations.
knowledge and understanding of Human Tissue Act and the Human Tissue Authority (HTA) codes of practice, GLP, GCLP, Good Research Practices and their applicable regulations (domestic and international), quality principles, relevant business processes and techniques.
Fosters a quality culture of shared accountability and knowledge sharing through inspiring, motivating, influencing, teaching and coaching others.
Knowledge regarding the use of electronic systems in a regulated environment, and personal functional computer literacy
High level of personal integrity with a strong commitment to patient welfare and ethical behavior.
Fluent in written and spoken English. Additional language skills would be an advantage.
Able to travel nationally and internationally as business necessitates,20% of time on average.
Demonstrated self-starter, highly reliable, with positive, action oriented, enthusiastic approach, ability to manage own workload, set priorities within the remit allocated by management and willingness to accept responsibility.
Confident presenter and communicator, able to give presentations to interdepartmental audiences and represent company with externals and deliver clear verbal and written messages in a constructive and effective manner to a variety of audiences/recipients.
Skilled negotiator, able to influence and obtain cooperation from colleagues, business partners and other stakeholders, including senior management during audit process.
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. If you are interested, you can send your CV to [email protected] .
To evaluate the feasibility and risk associated with Capital Investment (CAPEX) projects.
To relay customer consideration and take benefit of his expertise in the definition of requirement (URS) and the solution design.
To ensure the management of the supplier until the FAT, SAT and commissioning.
To support the qualification according to company SOPs and ICH guidance.
When applicable to organize the process technical transfer.
This includes:
To elaborate the technical transfer strategy and to prepare/review of the test protocols. The input should be based on the coordinator’s technical background and the knowledge of the equipment to define a plan technically feasible and acceptable on GMP aspect.
To coordinate support departments (RA, QC, QA, Qualification/Validation, Development, Technical Services, Industrial IT, Supply Chain, HSE, Metrology, Sourcing, Facility, Finance, Utilities…) for projects implementation.
To prepare the equipment and to program the recipes on manufacturing equipment.
To ensure that the equipment runs properly and if needed to connect with supporting services (maintenance, IT and external supplier/service providers).
To deliver to the client the technological know-how capitalized during commissioning and qualification campaign.
To support the client department for pre-approval inspections of delivered new equipment and processes.
To identify, propose and implement technical solutions to improve plant capacities, to reduce COGS, to increase efficiency and improve Quality compliance.
To supervise the strict application of Safety & Hygiene rules and foster development of improved practices.
Skills and Knowledge Requirements
Knowhow in automation, packaging, and medical devices technologies
Senior experience on Project management methodology.
Prioritization skills and ability to successfully manage multiple tasks simultaneously.
Teamwork: ability to work well in highly cross functional and inter-site team environment.
Communication skills: ability to express clearly and concisely within a team. To adjust communication style for the audience. To timely and effectively communicate on issues.
Technical writing skills to support authorship of internal documentation.
Knowledge sharing: ability to capture and to digest information from multiple sources and to build intelligible knowledge to be shared with project clients.
Knowledge of GMPs
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 Aylin Ugurlu at [email protected]
Manages Non-clinical formulation activities related to the screening and CMC development of small molecule, peptide or other synthetic drug products (from discovery and preclinical stages to clinical formulation orientation work for First-In-Human). Typical formulations are microsuspensions, amorphous solid dispersions, and nanosuspensions.
Liaises with Non-Clinical formulation Leads to assure consistency between the development and the production of NCL formulation, and the project needs.
Manages protocols of development or production and participate to the planning of activities.
Participates to the development, characterization, and production of non-clinical formulations.
Performs the physico-chemical characterization and stability studies of new molecules (NCEs) on batches before the GLP batch. Typical characterization techniques are liquid chromatography (UPLC), thermal analysis (DSC, TGA), laser diffraction granulometry, optical and electron microscopy. Develops if needed new methods.
Analyses results with readiness to criticize and ensures the consistency of these results with earlier data if relevant.
Documents and verifies in an appropriate manner the whole of the performed activities (e.g. Electronical Lab Notebook)
Consolidates the results and write adequate reports.
Contributes to the writing of technical documents like SOPs, user guides, guidances, etc.
Participates to the advancement of the department’s Science & Technology and Innovation projects The scientist needs to be autonomous and think pro-actively, in collaboration with the Non-Clinical formulation lead. The need to already have an experience in formulation with a preference for Non-Clinical formulation development, with knowledge in the related analytical support. He needs to be flexible, well-organized, curious and have good communication and coaching skills. He needs to be able to combine multiple tasks and must adapt to priority changes.
Skills and Knowledge Requirements
Master/PhD: pharmaceutical sciences, formulation, analytical chemistry or equivalent
Min years’ experience required: 2-3 years in formulation domain, preferentially in non-clinical formulation field.
Key technical backgrounds: non-clinical formulation preparation, small molecule chromatography (HPLC/UHPLC)
Mandatory skills: team player, communicative, experience in a similar position/environment, compliant/rigorous, flexible, curious
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.
Analytical Development Analyst Contracting – Walloon Brabant
Your responsibilities ? Operational :
Develop and validate analytical methods to support projects in development in different phases of product development.
Perform analyses of raw materials, intermediate products, in bulk or pakaged finished products in accordance with work instructions and established procedures (stabilities, in-process control, clinical release, investigation, …).
Ensure stability analyses and clinical release for clinical phases I and II, as well as any analyses in support to process understanding (IPC test, forced degradation study, multimedia dissolution, …)
Analyze results with readiness to criticize and ensures the consistency of these results with earlier data if relevant.
Participate to analytical exercise transfer to QC and subcontractors.
Monitor the documentation associated with the analytical laboratory activities by mastering the computer softwares in use at the laboratory (eg Mikado, GLIMS, e-noval, TrackWise, …).
Quality :
Make sure to have received and understood all the information and instructions required for the tasks before starting work.
Respects the procedures and reports any discrepancies to the responsible
Use authorized and validated methods prior to testing, if applicable.
Respect and properly maintain the analytical equipment and facilities at disposal.
Performs double check the team
Your profile ?
Master or Bachelor: analytical chemistry
Key technical backgrounds: small molecule chromatography (HPLC/UHPLC/GC) and detection techniques (UV/Vis, MS), USP/EP Pharmacopoeias
Mandatory skills: team player, exp. in a similar position/environment, compliant/rigorous (understands the importance of following procedures in detail)
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]
For our client specialized in the design, development and supply of advanced technology solutions in the fields of Defence and Homeland Security, we are looking for a senior system engineer
Your Mission The Senior Systems Engineer role focuses on business development, sales, and project management for international institutional clients within public tender processes. Key responsibilities include:
Technical Pre-Sales Support: Identifying clients’ technical needs, tracking market and competitive trends, defining solutions, and preparing commercial offers.
Design and Development of Complex Solutions: Leading analysis, definition, design, integration, testing, and support of systems in the defense and security sectors.
Technical Expertise (SME): Providing end-to-end technical expertise and serving as the subject matter expert for certain technologies.
Relationship Development: Building strong relationships with clients and OEMs, participating in marketing events, and anticipating purchasing cycles.
Your Profile
Education: Engineer in electronics, technical sales, mechanics, or electrical engineering.
Technical Experience: Strong background in the design, integration, and implementation of integrated HW/SW solutions.
Skills: Knowledge in electronics, radiofrequency, telecommunications, and IT.
Pre-Sales Experience: Experience in technical pre-sales, analyzing tenders, negotiating, and managing suppliers within advanced technology companies.
Languages: Proficiency in English is mandatory; additional languages like Dutch, German, or Arabic are advantageous.
Software: Proficiency in MS Office tools.
Personality: Capable to work under pressure, prioritize, stay organized calm and focused.
Nationality and Authorization: EU citizenship with valid work permit and residence visa.
Nice to Have: Knowledge of PLC/HMI, radar and RF systems, digital communications, day/night optical solutions, 3G/4G/5G communications.
Our offer We offer you a permanent contract and an attractive salary package. You will also benefit from the opportunity to develop personally and professionally through in-house training.
Do you have solid experience in payroll? Are you fluent in Dutch and ready to contribute to efficient and accurate payroll processes? This opportunity might be for you!
About the job
Contract: 3/5 Location: Leuven Start: As soon as possible for a 7-month assignment, with the possibility of extension
Your Responsibilities
As a Payroll Consultant, you will play a key role in managing payroll and optimizing HR administrative processes. Your main duties will include the accurate calculation of gross entitlements for fringe benefits, managing working hours, and applying social legislation rigorously.
Tasks:
Calculate employee entitlements on gross amounts within the scope of fringe benefits
Ensure compliance with current social legislation
Manage working hours and absences for payroll
Analyze and correct any discrepancies in payroll processes to ensure reliability and propose solutions to address recurring issues
Participate in team meetings and communicate progress on payroll projects clearly and concisely
Collaborate with other departments to improve processes and ensure consistency in HR data
Who You Are
Proven experience in payroll
In-depth knowledge of social legislation
Proficiency in payroll and office tools (Excel and Word)
Familiar with SAP, Syntegro, and Workday (a plus)
Languages: Native-level Dutch (C2), Intermediate French (B2)
Ability to communicate clearly and concisely to ensure smooth operations
What You Can Expect
A challenging contract and rewarding assignment within a growing hybrid company. Competitive salary based on your skills and experience. This opportunity will allow you to develop your skills and grow within a dynamic team.
Interested in this role? Send us your application and join an exciting HR adventure!
Ce poste fait partie de l'équipe Supply et logistique. Les membres de l’équipe Supply assurent l’approvisionnement en matières et matériel afin d'assurer les activités GMP et non-GMP. La principale responsabilité sera la gestion des Specification et des Change Notification pour les produits biologiques et les thérapies géniques.
Responsabilités
Assurer la création et la mise à jour des spécifications / FIP et des documents associés (TSE/BSE, Certificats…) pour les matériaux et consommables utilisés en collaboration avec les laboratoires et les ingénieurs process.
Évaluer/documenter les Change Notification de la Pharmacopée ayant un impact potentiel sur les produits utilisés et mettre en œuvre des actions si nécessaire.
Gérer l’évaluation des notifications de changements des fournisseurs pour les matières premières et définir des actions associées.
Participer activement au système de gestion des déviations (ouverture de PR, investigations, CAPA, Change control…) et s’assurer de leur réalisation en temps et en heure
Gestion logistique des vêtements nécessaire au bon déroulement des activités GMP et le suivi du fournisseur associé
Participer aux activités de sécurité
Connaissances et Expériences Requises
Esprit organisé et systématique
Excellentes compétences en communication, dans la mesure où vous interagissez avec différentes équipes/parties prenantes : opérateurs, responsables de la production, équipe de validation, QA.
Esprit d'amélioration continue.
Maîtrise du français et bonne connaissance de l'anglais
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] .
Projectingenieur (M/V) Vast Contract – Regio Sint Niklaas #engineering #staalbouw #projectmanagement
Heb je een diploma industrieel ingenieur (elektromechanica of bouwkunde) en ervaring met projectbeheer in staalconstructies of constructiewerken? Ben je sterk in technisch ontwerpen, berekeningen en het coördineren van projecten? Dan is deze functie wellicht iets voor jou!
Onze klant, een specialist in op maat gemaakte magazijninrichtingen, is op zoek naar een Projectingenieur om hun team te versterken. Ben je klaar om deze uitdaging samen met Jefferson Wells aan te gaan? Lees dan zeker verder!
Verantwoordelijkheden In deze rol ben je de spilfiguur in het ontwerp, de berekeningen en de realisatie van op maat gemaakte magazijninrichtingen. Jouw takenpakket:
Ontwerpen en Berekenen: Verantwoordelijk voor sterkte- en stabiliteitsberekeningen voor magazijninrichtingen, zoals tussenvloeren, wanden en rekken.
Projectbeheer: Je beheert het volledige traject, van bestellingen plaatsen tot het controleren van verkooptekeningen en het coördineren van de montage.
Technische Ondersteuning: Biedt technische ondersteuning aan verkopers en monteurs om ervoor te zorgen dat de klantoplossingen naadloos worden uitgevoerd.
Wie ben jij? Je hebt een diploma industrieel ingenieur elektromechanica, bouwkunde of een vergelijkbare richting, en beschikt over minimaal 3 tot 5 jaar ervaring in een soortgelijke functie, bij voorkeur in staalbouw of constructiewerken. Je hebt ervaring met sterkte- en stabiliteitsberekeningen en werkt vlot met Autocad 2D. Naast een uitstekende beheersing van het Nederlands, kun je je ook goed uitdrukken in het Frans. Je bent stressbestendig, denkt probleemoplossend en werkt graag nauw samen met verschillende teams.
Praktische kennis van lascoördinatie is een pluspunt, maar indien nodig biedt het bedrijf een cursus aan!
Wat kan je verwachten? Als Projectingenieur krijg je de kans om deel uit te maken van een groeiend en dynamisch bedrijf waar ruimte is voor ontwikkeling en zelfstandigheid. Je ontvangt een competitief salaris, aangevuld met extralegale voordelen, en krijgt de mogelijkheid om je verder te ontwikkelen via interne opleidingen. Daarnaast werk je in een collegiale werksfeer met de mogelijkheid om reële carrièremogelijkheden te realiseren.
Ben je geïnteresseerd in deze uitdagende functie? Neem dan contact op met Sara Van den Bossche via [email protected] of bel naar 0472.79.10.42.
We kijken ernaar uit om jou te ontmoeten en samen de perfecte match te vinden!
R&D Engineer Vast contract – Regio Roeselare #RDEngineer #AgriculturalMachinery #Innovation Heb jij een masterdiploma in elektromechanica en ervaring in machinebouw? Heb je een passie voor landbouwmachines en wil je bijdragen aan innovatieve productontwikkeling? Werk je graag in een dynamische omgeving waar je samen met collega’s nieuwe oplossingen bedenkt en test? Lees dan zeker verder! Onze partner is op zoek naar een R&D Engineer om hun team te versterken. Dit toonaangevend bedrijf in de landbouwsector staat bekend om zijn innovatieve machines en hoogwaardige service wereldwijd.
Jouw verantwoordelijkheden:
Je ontwikkelt en ontwerpt innovatieve oplossingen voor bestaande producten.
Je begeleidt je eigen ontwerp van concept tot in het veld
Je ondersteunt bij de bouw van prototypes en test ze samen met de klant.
Je lost technische problemen in productie en after-sales op en je adviseert oplossingen.
Je helpt mee aan het ontwerp, opbouw en testen van nieuwe producten, prototypes en 0-serie.
Wie ben jij? Je hebt een master in elektromechanica en relevante ervaring in de machinebouw. Als teamspeler neem je graag verantwoordelijkheid voor jouw deel van het project. Ervaring met 3D-software zoals Creo Parametric, of een vergelijkbaar pakket, is een pluspunt. Je bent praktisch ingesteld, oplossingsgericht en hebt een hands-on mentaliteit. Afwisseling in je werk spreekt je aan; je voelt je zowel thuis in het ontwerpen als in het meewerken aan de productie. Daarnaast ben je flexibel en bereid om tijdens piekperiodes extra inzet te tonen.
Wat kan je verwachten ? Als R&D Engineer krijg je een aantrekkelijke verloning aangevuld met een uitgebreid pakket aan extralegale voordelen en een onmiddellijk vast contract van onbepaalde duur. Ten slotte geniet je de mogelijkheid om jezelf persoonlijk en professioneel te ontwikkelen door interne trainingen en opleidingen. Ook freelancers komen in aanmerking voor deze functie. Voldoet deze vacature aan je verwachtingen? Solliciteer dan via de website of contacteer Martine Vergote op het nummer (+32) 0495 365142 of met CV naar Martine.Vergote (at)Jeffersonwells.be
Raw material scientist Role Summary The Raw Material Scientist is a technical expert responsible for establishing and coordinating a comprehensive strategy to identify critical/key raw materials during development to support process development decision making. They will support the definition of appropriate technical controls and the implementation these practices during the development of biologics and gene therapy products to improve process robustness, cost efficiency, and readiness for regulatory submissions. Key Accountabilities
Generate risk assessments strategy for current raw materials and identify critical and key ones from a process and supply point of view.
Support the QbD initiative on raw material and GRAM exercise (CMA KMA definition, generate guideline and templates).
Define based on risk assessment mitigations and controls to be implemented in collaboration with appropriate teams (in production, release at supplier, shipment, storage, during usage).
Support the design supportive studies required.
Support the introduction of new raw materials in close collaboration with process teams (supplier selection criteria at early stage, IPC/specifications definitions, shelf life definitions, ..)
Improve raw materials usage in collaboration with process development and clinical manufacturing.
Create and lead satellite communities per expertise to facilitate exchanges, identify gaps and mitigations, build strategies on lessons learnt and successes to prepare future.
Author & review technical documents including CMC regulatory sections, SOPs, technical position papers, & technical reports.
Accumulate knowledge based on lessons learnt, investigation and literature on potential risks, quality and regulatory requirements and suggest alternatives.
Collaborates with internal and external partners to stay abreast of industry trends and emerging risks related to raw materials, regulatory and quality requirements evolution, best practices.
As a member of the DSPS team, the raw material scientist may work transversally across projects and groups in line with the needs of the business and as part of the CMC Development Sciences organization.
Critical Competencies & Experiences Required
At the very least 2 years of experience in CMC development within the biopharmaceutical industry.
Demonstrated ability to successfully co-ordinate project activities and manage meetings.
Good interpersonal skills in order to communicate with and maintain fruitful working relationships with colleagues across departments and geographies, as well as external partners.
Basic knowledge of regulatory guidelines, safety, and quality requirements for raw materials.
Ability to learn proactively.
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]
