Internal Operations Quality Partner

Location: Braine-l'Alleud, Région wallonne, Belgique
Job #26936

Internal Operations Quality Partner

Contracting – Brabant Wallon

Your responsibilities:
The role is within the Clinical Supply Quality team, focusing on packaging and labeling for clinical studies. The position is critical for ensuring quality systems and compliance in the production, release, and distribution of Investigational Medicinal Products (IMPs) for clinical trials.

– Review of batch records (both electronic and paper).
– Review and release of labels.
– Release of warehouses and production consumables specification.
– Update of CEC (Controlled Environment Conditions).
– System-related activities: deviation review, CAPA (Corrective and Preventive Actions), change control.
– Temperature excursion management.
– Validation activities related to computer design systems.
– Documentation review for operational production activities.
– KPI realization based on specific requests.
– Participation in audits, regulatory inspections, and vendor management.
– Support for qualification, validation, and maintenance of equipment and facilities.

Your profile:
– 3 to 5 years of relevant experience required.
– Pharmaceutical experience is essential; QA/compliance experience in a pharmaceutical regulated environment.
– Proficiency in Excel (KPI creation, pivot tables).
– Hands-on operational QA experience is important and will make a difference.
– Good knowledge of cGMP and relevant regulatory requirements (e.g., US, European, Japanese).
– Technical affinity (e.g., point of contact for equipment validation).
– Dynamic, energetic, and communicative personality, able to challenge and express opinions.
– Fluency in English and French.
– Preferably a Master’s degree in engineering or similar for the right mindset.
– Ability to function with minimal supervision, strong organizational and analytical skills.
– Fact-based decision-making and problem-solving skills (failure investigations, risk analysis).

—- No QP (Qualified Person) number required, but QP training is a plus.

Nice to Have:
– Certified auditor by official authorities.
– Eligibility to act as a QP in the EU.
– Experience in leading internal audits/self-inspections.
– Familiarity with regulatory submissions and CMC (Chemistry, Manufacturing, and Controls) documentation.

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]

Production & Planning Manager

Location: Dilbeek
Job #26941

Brabant Flamand – CDI

Pour notre client spécialisé dans la production graphique haut de gamme, nous sommes activement à la recherche d'un Production & Planning Manager, dans la périphérie de Bruxelles.

#production #engineering #industrie #industriel #management

Votre rôle

En tant que Production & Planning Manager, vous êtes le moteur d’un de nos départements de production. Vous dirigez une équipe d’une dizaine d’opérateurs, organisez le planning quotidien et garantissez un flux de production efficace.

Au-delà de la planification, vous êtes un véritable leader: vous motivez, formez et développez votre équipe pour atteindre les meilleurs résultats. Avec le team coach, vous créez une culture de travail positive et orientée résultats.

Vous assurez la coordination optimale entre production, ventes et opérations. Vous faites partie du Production Management Team et rapportez directement au Operations Director.

Responsabilités principales

Encadrer, motiver et coacher l’équipe de production au quotidien
Assurer une organisation efficace du travail et définir les priorités
Élaborer, suivre et ajuster les plannings de production
Garantir la qualité, la productivité et le respect des délais
Identifier et mettre en œuvre des améliorations de processus
Collaborer étroitement avec les équipes commerciales, planning et logistique
Maintenir la sécurité, l’ordre et la propreté au sein du département
Rapporter les performances et actions d’amélioration à la direction

Votre profil

Master ou expérience équivalente en gestion de production/operations
Expérience confirmée dans la gestion d’équipe en environnement industriel
Leadership fort: terrain, communicatif, orienté résultats
Bonne connaissance des processus de production et normes qualité
Analytique, structuré et résistant au stress
Excellentes compétences organisationnelles et administratives
Maîtrise du néerlandais, du français et de l’anglais
Expérience ERP / logiciels de planification est un atout
Envie d’apprendre et de grandir avec l’entreprise

Vendor Quality Lead & QP

Location: Braine-l'Alleud
Job #26956

Vendor Quality Lead – QP
Contracting – Walloon Brabant

Our partner is currently looking for a Vendor Quality Lead to join its team. This international company is well-known for its pharmaceuticals.

What are your responsibilities?
In this position, you will support the Qualified Person (QP) in relation to all batch release activity for Global products produced by third parties, primarily performing QA review of batch documents, issue of batch certificates, and transactional release activities.

Vendor Quality Lead (VQL) related accountabilities:

Be the central QA point of contact for the organization for investigations/deviations/ out of-specifications/ audit observations associated with the assigned vendors.
Perform the QA review of deviation notifications, retrieve and collect supportive information from involved stakeholders allow assessment.
Manage the key performance indicators (metrics) for key operational QA activities and services associated with the vendors in the defined described tracking tools and track the vendor’s performance.
Ensure all Quality agreements are in place and take ownership of agreements for the vendors. Maintain Quality Agreement with the vendors up to date and perform periodic reviews and update of the agreement in close collaboration with the product CMC Quality Leads and the vendors.
When applicable, be sure that the Annual Product Stability Program is rolled-out and executed at the vendor in accordance with the internal Stability Program
Ensure the Product Quality Reviews (PQR) are completed by the vendors in a timely manner and as needed, are reviewed within the requested time period. Ensure that this review is documented and made available in the internal Controlled Documents System.
Participate as QA representative to the recurrent vendor meetings, present issues and resolutions, and drive vendor quality performance through these meetings.
Quality Complaints: Be the contact person for the follow-up with vendors for the manufacturing investigation part. When applicable, ensure that initial receipt, logging of quality complaints into the Complaint System and provision of responses to the complainant are professionally coordinated and managed.
Provide expert QA advice, support and management for technical operational QA and general QA matters associated with the vendors.
Work closely with Corporate QA teams, Technical Operation Teams, Business stakeholders and Affiliates in an effective and efficient way.
Cover the entire product life cycle from initial commercialization including Technology Transfer/Knowledge transfer, commercial (key raw materials to distribution), product improvements to phase out for the assigned vendors.
Owner of the QA plans and product resource and capacity overview for activities associated with the assigned vendors.

Qualified Person related accountabilities:

Support the QP in relation to all batch release activity, primarily performing QA review of batch documents.
Issue batch certificates for product release and distribution
Perform in SAP the transactional product release and maintenance of batch release register
Liaise with Vendor Team(s) and CMO’s where applicable on resolution of issues relating to document errors to support release.
Act as QA contact (in conjunction with site QP) and deputize on behalf of QP where appropriate for product related quality issues and associated communications.
Act as a contact with other departments and Affiliates to support the drug product /Finished goods release process and supply of post release documents.
Maintain and report Metrics relating to batch release activities.
Support Global Regulatory Affairs and CMC Quality Leads for submission document requests
Coordinate legalization/notarization of documents as needed

Who are you?

Eligibility as a Qualified Person in EU
Must be knowledgeable in several areas of the global pharmaceutical industry, including the interpretation and practical application of applicable regulations.
Has good background knowledge of the pharmaceutical industry from a business and technical perspective.
Must be able to act in most circumstances without direct supervision and handle complex / difficult situations. Output from actions will most likely impact activities across several departments.
Must be able to effectively interact with and influence senior internal and external personnel on many aspects of project and product related matters.
Be capable of leading and motivating teams and demonstrate professional maturity in difficult situations.

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.

Batch Record Reviewer

Location: Antwerp
Job #26943

Batch Record Reviewer

Contracting – Antwerp

De Batch Record Reviewer is verantwoordelijk voor het voorbereiden, controleren en finaliseren van batchrecords.
Je maakt deel uit van het Batch Record Review Team, een divers team dat batches voorbereidt en beoordeelt binnen de verschillende productie-eenheden.
Nauwe samenwerking met Operations en Quality over de afdelingen heen is essentieel voor deze rol.

Belangrijkste Taken en Verantwoordelijkheden

Uitgebreide review van productie- en reinigingsbatchdocumentatie.
Opstellen van batchtrends voor elke productie- en reinigingsbatch en controleren op volledigheid en eventuele afwijkingen.
Aanvullen van batchdocumentatie met noodzakelijke bijlagen (bijv. eLIMS-resultaten).
Controleren van volledig en correct grondstofverbruik.
Verifiëren, registreren en opvolgen van afwijkingen binnen elke batchrecord.
Correct classificeren van afwijkingen volgens procedures en, indien nodig, initiëren van non-conformiteiten.
Archiveren van batchrecords conform de kwaliteitsrichtlijnen.
Voorbereiden en structureren van batchdocumentatie.

Kwalificaties

Opleiding en/of Ervaring

Je kunt documentatie nauwkeurig en punctueel beoordelen.
Je werkt gestructureerd en kunt effectief prioriteiten stellen.
Je beschikt over sterke communicatievaardigheden.
Je spreekt en leest vloeiend Nederlands.

Ons aanbod
Jefferson Wells biedt je een vast contract als consultant met een aantrekkelijk salarispakket en toegang tot opleidingen, zowel technisch als op het vlak van soft skills. Wij worden jouw carrièrepartner en begeleiden je bij elke stap in je professionele groei.
Ben je geïnteresseerd in deze functie? Dan nodigen we je graag uit om te solliciteren of je cv te sturen naar [email protected].

Quality system contractor

Location: Braine l'Alleud
Job #26926

Quality System Contractor
Brabant Wallon – Contracting

What are your responsibilities?

Support and prepare for regulatory inspections and audits.
Lead or assist in Quality Council and Risk Management Committee activities.
Develop and maintain internal audit and self-inspection programs.
Structure and align local documentation with global standards.
Implement and lead local Quality System Reviews.
Promote quality culture and regulatory awareness among staff.
Act as a mentor/coach for quality and regulatory requirements.
Benchmark industry trends and support local/global quality initiatives.

Who are you?

Minimum 8–10 years of experience required in pharmaceutical quality systems.
Pharmaceutical industry experience.
Demonstrated experience in quality systems and compliance.
Experience in audits and inspections.
Ability to work autonomously and proactively.
Fluent in French and English.
Strong interpersonal skills; not afraid to reach out and follow up with colleagues.

Nice to have:

Experience with biological drug substance (business and/or quality).
Agility to handle unpredictable changes and a stressful environment.
Experience collaborating and influencing across departments.
Additional certifications in quality or regulatory affairs.

Mechanical Design Engineer

Location: Kontich
Job #26927

Mechanical Engineer
Vast Contract of freelance – Regio Mortsel
#MechanicalEngineering #MachineDesign #ProcessOptimization

Ben jij een analytisch ingestelde en leergierige engineer die houdt van het ontwerpen en verbeteren van mechanische systemen?

Als Mechanical Engineer krijg je de kans om jouw kennis van machinebouw toe te passen en uit te breiden binnen een internationale en innovatieve omgeving waar kwaliteit, veiligheid en duurzaamheid centraal staan.

Jouw verantwoordelijkheden?
Als Mechanical Engineer werk je nauw samen met de Director ME & EE en de Project Manager en ben je verantwoordelijk voor:

Ontwikkelen van nieuwe mechanische blokken en verbeteren van bestaande mechanische onderdelen.
Ontwerpen van mechanische onderdelen en continu optimaliseren van kennis over machinebouw en tekenpakketten (CREO, Windchill, AutoCAD).
Beheren van de uitvoering en kwaliteit van engineeringtaken en rapporteren van status en timing aan de Director ME & EE.
Overleggen met de assembly-afdeling en leveranciers over oplossingen voor concrete designs en opstellingen.

Wie ben je?
Je hebt een Bachelor in Elektromechanica of gelijkwaardige ervaring en inzicht in de opbouw en werking van machines. Je bent nauwkeurig, analytisch en beschikt over een sterke teamspirit. Je werkt vlot in Nederlands en Engels, en bent vertrouwd met SAP, MS Office en tekenpakketten zoals CREO, Windchill of AutoCAD.

Wat kan je verwachten?
Als Mechanical Engineer kom je terecht in een internationaal georiënteerd en technologisch vooruitstrevend bedrijf waar initiatief en persoonlijke ontwikkeling worden gestimuleerd. Je krijgt de kans om complexe projecten te begeleiden, je technische expertise verder uit te bouwen en actief bij te dragen aan procesoptimalisatie en duurzaamheid. Daarnaast mag je rekenen op een aantrekkelijk loon- en voordelenpakket, een bedrijfswagen met tankkaart en een GSM-abonnement.

Freelancers komen ook in aanmerking!

Voldoe jij aan dit profiel en wil je impact maken binnen een innovatieve mechanische engineeringomgeving? Solliciteer dan rechtstreeks via de website of contacteer Sara Van den Bossche op +32 (0)472 79 10 42 of via [email protected].

Reliability Engineer

Location: BUGGENHOUT
Job #26920

Reliability Engineer
Vast Contract of freelance – Regio Dendermonde
#ReliabilityEngineering #Maintenance #ProcessOptimization

Ben jij gepassioneerd door het verbeteren van productieprocessen en het verhogen van de betrouwbaarheid van industriële installaties? Werk je graag op het snijvlak van techniek, onderhoud en procesoptimalisatie? Dan is deze rol als Reliability Engineer iets voor jou!

Samen met Jefferson Wells krijg je de kans om jouw technische kennis in te zetten binnen een dynamische productieomgeving, waar continue verbetering en innovatie centraal staan.

Jouw verantwoordelijkheden?
Als Reliability Engineer ben je verantwoordelijk voor de betrouwbaarheid van alle productielijnen en werk je actief aan het verbeteren van het onderhoudsproces. Je taken omvatten onder andere:

Melding van veiligheidsrisico’s en uitwerken van preventieve maatregelen met als doel 0 arbeidsongevallen.
Opstellen en bijsturen van het preventief onderhoudsplan in het werkordersysteem met technieken zoals RCM, PMO en RCA.
Verbeteren van de efficiëntie van kritische installaties, reduceren van onderhoudskosten en verminderen van SHEQ-incidenten.
Registratie en analyse van productiedata, onderhoudsdata en werkhistoriek om aanbevelingen te doen.
Leiding nemen over RCA-workshops (Root Cause Failure Analysis) en verbeteringsvoorstellen uitwerken.
Faciliteren van meetings om onderzoeksstrategieën te herzien en de minst presterende systemen te verbeteren.
Actief bijdragen aan Capex-projecten door input te geven over betrouwbaarheid aan het Engineering/Projectteam.

Wie ben je?
Je beschikt over een Technische Bachelor of gelijkwaardig door ervaring, en hebt minstens 2 jaar ervaring in een technische omgeving. Je combineert sterke mechanische, elektrische en automatisatiekennis met ervaring in preventieve onderhoudsprogramma’s en tools zoals trillingsanalyse, oliemonitoring en thermografie. Je bent vaardig met computersystemen en hebt kennis van technieken en tools gerelateerd aan reliability engineering. Je bent analytisch, creatief en probleemoplossend ingesteld en kunt prestatieverbeteringen binnen werkgroepen stimuleren. Je leert snel, denkt innovatief en bent resultaatgericht, en je functioneert uitstekend in teamverband.

Wat kan je verwachten?
Als Reliability Engineer mag je rekenen op een aantrekkelijk loonpakket, aangevuld met extralegale voordelen, bedrijfswagen met tankkaart en een gsm-abonnement. Daarbovenop ook de mogelijkheid om je technische expertise verder te ontwikkelen via opleidingen en impact te maken op de betrouwbaarheid en prestaties van de productielijnen.

Freelancers komen ook in aanmerking voor deze functie.

Voldoe jij aan dit profiel? Solliciteer dan rechtstreeks via de website of contacteer Sara Van den Bossche op +32 (0)472 79 10 42 of via [email protected].

Analytical Scientist

Location: Braine l'Alleud
Job #26914

Analytical Scientist

Contracting – Brabant Wallon

Your responsibilities:

Work on projects involving polymers, peptides, small molecules, and biomolecules.
Identify unknown impurities from production samples.
Develop analytical methods (high-resolution LCMS).
Participate in weekly project meetings.
Independently manage planning and lab work.
Prepare samples, process data, write reports, and present results.
Collaborate with the team to share instruments and knowledge.

Your profile:

Experience in mass spectrometry (high-resolution LCMS).

Skills in analytical method development.
Autonomous work style and ability to manage own schedule.
Good English proficiency (for meetings and international interactions).
Understanding and respect for GMP rules.
Ability to interpret complex spectra, especially for polymers and biomolecules.
Nice to Have:
Experience with polymers and large molecules.
Knowledge of biomolecules (proteins, antibodies).
Experience in a GMP environment.
Willingness to collaborate and support teammates.
Familiarity with various mass spectrometry instruments.

Construction Manager – Civil (Data Center Experience)

Location: Mons
Job #26318

Mons – Consultance/Freelance

Dans le cadre d'un projet de construction d'un Data Center, nous sommes activement à la recherche d'un Construction Manager – Civil, avec de l'expérience en Data Center, pour superviser et coordonner les travaux civils. Le candidat idéal possède une solide expérience dans la gestion de chantiers complexes, à fort volume et à rythme accéléré, avec une expertise spécifique dans les environnements techniques exigeants.

#engineering #datacenter #construction #civilengineering #civilwork #constructionmanager

Responsabilités principales :

Superviser l’exécution des travaux civils (exemples: les terrassements, le béton structurel, l’acier, le drainage et les voiries).
Gérer plusieurs sous-traitants, équipes internes et fournisseurs tiers sur site.
Assurer la coordination des interfaces CSA (Civil, Structural, Architectural).
Planifier et suivre l’avancement des travaux en respectant les délais critiques (critical path).
Participer à la planification logistique et au séquençage des corps d’état sur des sites à haute densité.
Veiller au respect des normes de qualité, de sécurité et des exigences du client.
Collaborer étroitement avec les équipes MEP, de conception et de gestion de projet.
Maintenir une communication fluide avec les clients.

Profil recherché :

Expérience de 7 à 10 ans dans la construction, dont 3 à 5 ans sur des projets Data Centers.
Expérience avérée dans la gestion de projets civils de grande envergure.
Expérience dans des environnements MEP.
Maîtrise des outils de planification et de gestion de projet.
Capacité à travailler sous pression et à gérer plusieurs priorités simultanément.
Excellentes compétences en communication, leadership et résolution de problèmes.
Expérience de travail directement pour des clients de niveau 1 (par exemple : AWS, Microsoft, Google, Meta).
Maîtrise du français. L'anglais est un atout.

Notre offre:

Jefferson Wells vous propose un contrat à durée indéterminée (CDI) en tant que consultant, assorti d’un package salarial attractif. Vous aurez accès à des formations techniques et en compétences comportementales (soft skills). Nous serons votre partenaire de carrière à chaque étape de votre parcours professionnel.

Intéressé(e) par cette opportunité ? N'hésitez pas à postuler !

Site Project Manager – HV Substation

Location: Dublin
Job #26462

Mons – Contracting / Freelance

As part of a Data Center construction project, we are actively seeking a Site Project Manager to lead the delivery of the 110kV substation project (Perun).

The successful candidate will be responsible for the full site execution of the project, managing all disciplines including civil, structural, electrical, mechanical, and commissioning works. This is a key leadership role requiring strong technical knowledge, excellent coordination skills, and the ability to drive performance, safety, and quality across all trades.

#construction #sitemanagement #projectmanagement #substation #highvoltage #electricity #civilwork #energy

Key responsibilities:

Lead day-to-day site operations to ensure timely and safe execution of all construction activities on a 110kV substation project.
Manage and coordinate all on-site trades: Civil, Structural, Architectural (CSA), Mechanical, Electrical (HV and MV), Protection & Control, Commissioning.
Serve as the primary site interface for client representatives, subcontractors, consultants, and the internal project team.
Chair daily briefings, weekly progress meetings, and toolbox talks.
Maintain strict compliance with health, safety, environmental, and quality standards.
Monitor progress against program, resolve site issues proactively, and escalate critical risks as required.
Drive productivity and ensure resources (labour, plant, materials) are available and effectively managed.
Oversee quality inspections, snagging, and documentation close-out processes.
Maintain site records including progress photos, daily diaries, permits, and safety audits.
Ensure coordination with DNO/TSO and other key stakeholders during outages, energisation, and commissioning phases.
Support commercial team with records for variations, claims, and valuations.

Requirements:

Minimum 7–10 years of site management experience, ideally with at least 3 years delivering HV substations (110kV or higher).
Proven ability to manage multidisciplinary teams and subcontractors on complex infrastructure projects.
Technical qualification in Engineering or Construction Management (Degree or Higher Certificate).
In-depth understanding of HV substation construction methodology and interfaces between trades.
Strong working knowledge of HSEQ legislation, Belgium regulations, and permit-to-work systems.
Proficient in reading drawings, schedules, and specifications across all disciplines.
Strong leadership, communication, and problem-solving skills.
IT literate – experience with MS Project / Primavera, MS Office, and document control systems.
SMSTS or equivalent safety qualification desirable.

Preferred Qualifications (Advantageous):

Authorised Person (AP) training or HV switching experience.
Experience with regulated utilities or transmission operators (e.g., Elia etc.).
Experience on EPC or turnkey contracts.
Knowledge of BIM coordination or digital construction tools.

Offer:

Join a forward-thinking engineering contractor delivering major energy infrastructure projects.

Be part of a team committed to technical excellence, reliable project delivery, and continuous professional development.

We offer a competitive salary package along with performance-based benefits.