Labelling implementation & partner specialist

  • Location: Braine l'Alleud
  • Job #24194

Labelling implementation & partner specialist

Brabant Wallon – contracting 

Our partner is looking for a Labelling implementation & partner specialist to strengthen its team. This international company is well-known for its research, development, and marketing of pharmaceutical and vaccines. 

What are your responsibilities?

Product launches, regulatory variations or technical updates requiring modification of printed components:

  • Ensure correct impact analysis of any Regulatory and other change requests from partners and implementation in all company's systems and Supply Chain
  • Manage and coordinate the implementation project in artwork management system and ensure the tracking and follow up of all project tasks to deliver within legal time and other project due dates.
  • Perform Write-off determination process
  • Create and extend Finished Good and Printed Components codes in Master Data Management (MDM) system and SAP.
  • Launch and manage master data collaborative workflows to ensure on time implementation
  • Update Bill of Material in line with legal requirements
  • Issue Master Packaging Sheet to ensure that CMOs are in possession of the necessary information for packaging the Finished Goods
  • Launch deactivation of Finished Goods in master data collaborative workflows
  • Continuous Improvement Responsibilities: Assist in continuous improvement of the Partner related internal master data and artwork processes as well as in the business processes and collaboration with Partners.

Who are you ? 

  • Bachelor's Degree

  • Service minded with very good written and verbal communication skills
  • Problem solver
  • Structured, detail minded and well organized
  • Stress resistant, accepts to be challenged and to challenge others
  • Open minded, flexible and team oriented; capable of doing the extra mile to reach targets
  • Fluent in English (written and oral), French is an asset  

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. 

Supply Officer

  • Location: Braine-l'Alleud
  • Job #24120

Supply Officer

Brabant wallon – Contracting 

Vos responsabilités ?  
L’équipe Supply assure les différents flux logistiques et supporte les activités de productions. Les membres de l’équipe Supply assurent l’approvisionnement en matières et matériel afin d'assurer les activités GMP et non-GMP du BioPilot. Ils contribuent à la gestion de la logistique (Commandes, réceptions, transferts entre magasins, vêtements de travail, approvisionnement de matières, élimination de déchets,…).

  • Coordination de projet – implémentation de XFP
  • Être le point de contact pour le projet d’implémentation de XFP
  • Prendre le lead et suivre les actions bloquantes ou en attente pour l’implémentation de XFP
  • Diriger ou soutenir l’implémentation de solution relatif à l’implémentation de XFP
  • Former les équipes opérationnelles à l’utilisation de XFP
  • Participer à l’écriture, la mise à jour des procédures impactées par l’implémentation de XFP
  • Soutenir l'équipe opérationnelle pour la fabrication de DS après la mise en oeuvre de XFP

Votre profil ?

  • Très bonne connaissance de SAP
  • Bonne connaissance Excel, Word, Powerpoint
  • Expérience dans le contact fournisseur

Notre offre ?
Nous vous offrons un contrat à durée indéterminée ainsi qu'un package salarial attractif. Vous profiterez également de l'opportunité de vous développer personnellement et professionnellement à travers des formations internes.
 

Quality Assurance Leader (GLP)

  • Location: Liège (Sart-Tilman),
  • Job #24170

Quality Assurance Leader (GLP)

Liège | Contracting

Your function / Main responsibilities :

· Contribute to meet GLP regulatory compliance for the Test Facility (OECD guidelines)

· Ensure implementation of processes and systems (e.g. facilities, equipment, personnel, methods, practices, records) according to the GLP non-clinical program of the Test Facility

· Support the maintenance and continuous improvements of the QMS system

· Prepare and/or review controlled documents (e.g., standard operating procedures, policies, CAPAs, change controls, master schedule)

· Review of study plans and study reports, amendments and deviations

· Prepare the quality assurance program statement of the study plans and reports

· Conduct facility-related, study-related and process-related inspections to ensure compliance with applicable GLP regulatory requirements

 

Your Profile :

· A master’s degree in life sciences or closely related fields

· Prior experience in non-clinical quality assurance and GLP regulations (3+ years)

· Strong knowledge of GLP OECD guidelines

· Strong knowledge in non-clinical research

· Past experience in CRO is a plus

· Familiar with standard lab techniques (cell culture and molecular biology) is a plus

Soft skills :

· Proficiency in both written and spoken English

· Excellent communication, organizational and scheduling skills, with ability to execute projects on time

· Solution-oriented way of working, problem-solving and analytical way of thinking

· Ability for rapid adaptation, pro-activity and autonomy

Team spirit and willingness to integrate a small structure where flexibility is a key factor

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 me
 

Associate Scientist

  • Location: Braine l'Alleud
  • Job #24149
Associate Scientist
Our client is looking for a Associate Scientist to join its team.
The team is based both in Slough and Braine and is responsible for developing processes – scale up and piloting of the processes (cell-culture processes – focused on the upstream side of the process). One important aspect is harvesting – once the cells are grown in the bioreactor, and they get them to express the product, the team has to crude purification to remove cells from the product. The type of cells are CHO cells. Another aspect is understanding the scaleup and the transfer to the next scale of the manufacturing in the BPP biopilot (GMP facility).

In short, growing cells, developing the process, keeping them healthy and getting them to express the biologic molecule that is then purified and eventually reaches the patient.

Working with:
• Benchtop bioreactors systems, such as Amba systems, Sartorius,
• Larger scale piloting systems
• single-use bioreactors
• shake flasks,
• anything on which cell process can be run

What are the responsibilities?
The position is primarily lab-based:
– A mix of documentation.
– Preparing the protocol and the documents.
– Preparing the experimental designs and preparing the experiments.
– Making buffers
– Preparing meetings.
– Building bioreactor vessels
– Sterilizing equipment
– Running the bioreactor
– Keeping the cells nice and healthy throughout the whole process
– Monitoring, measuring, taking samples, recovering the product
– Doing harvest and clarification
– Working with colleagues from other departments.
Experience and Knowledge requirement
Must have
– Process development experience
– Knowledge of cell culture and bioreactor processes (any scale, pilot scale preferably)
– Experience with benchtop bioreactors systems, such as Amba systems, Sartorius, larger scale piloting systems, single-use bioreactors, shake flasks, aseptic techniques, etc.
– Minimum 2 years of experience
– Fully fluent in English, French is a nice to have

Nice to have
– Knowledge/experience with harvesting and clarifying processes – clarification, centrifugation, centrifuge operations, filtration
– Experience with antibody expression, recombinant protein expression
– GMP experience

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]

 

Medical Monitor and physician for shigella and iNTS projects

  • Location: Braine l'Alleud
  • Job #24144

R&D clinical
Contracting – Braine l’Alleud
Our client is looking for a profile to fill a position in R&D clinical development. The role involves clinical studies in F1 and F2.

What are the responsibilities?
• Activities related to the design, and everything related to the analytical development.
• Taking the lead on protocols studies

Experience and Knowledge requirement
• Proven project management skills
• Experience in medical monitor for vaccines studies
• Degree or background in the medical field or proven experience
• Nice to have: clinical method development plan management
• Fully fluent in English both written and spoken

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]
 

Drug Product Expert

  • Location: Wavre
  • Job #24145
Drug Product Expert
Contracting – Wavre
Our client is looking for a Drug Product Expert to join its team. The role involves protocols related activities and communication with stakeholders.

What are the responsibilities?
• Activities related to protocols: aligning to a protocol and reviewing protocols, experiments, etc
• Communication with stakeholders both internal and external
• Interaction with the QA and RA
• DP development – development of small molecules, from the first studies to scale up.

Experience and Knowledge requirement
Must have
• Experience in the pharmaceutical industry
• Knowledge of GMP
• Fully fluent in English both written and spoken
• Proven experience in DP on small molecules

Nice to have
• Proven experience in project lead experience
• Dosing for injectables
• Knowledge of tablet manufacturing

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]
 

Sites and infrastructure Partner

  • Location: Braine l'Alleud
  • Job #24152

Sites and Infrastructures Partner
Our client is looking for a Sites and infrastructure Partner to join its team.
The role
Sites and infrastructure Business Engineering Partners serve as the central point of contact and a robust bridge connecting the Business area, Engineering, and Project Leaders for various facilities infrastructure aspects (such as buildings, roads, parking, landscaping….).
The role includes:

  • Strategic Perspective: Consolidate the overall technical perspective of the business area.
  • Budget and Feasibility: Accountable for delivering feasibility and design studies. within the budget for the 10-year plan.
  • CAPEX Coordination
  • Engineering Support: Sites and infrastructure Business Engineering Partners coach and mentor Engineering Managers, ensuring strong technical deliverables for CAPEX Projects.
  • Resource Allocation

What are the responsibilities?

  • Understanding Customer Needs:
  • Gather and comprehend requirements from customers.
  • Assist customers in articulating their needs to create a GP0 (General
  • Proposal).
  • Scenario Development:
  • Think creatively and prepare various scenarios.
  • Present these scenarios to stakeholders.
  • Project Initiation (GP0 Approval)
  • Support the Sponsor or Idea Owner in launching the project.
  • Collaborate with the Technical Engineering Team to identify the Project
  • Leader (PL) and establish the team structure for GP1 (Detailed Proposal).
  • Drive the project toward achieving GP1.
  • Coach the Project Leader on following the methodology.
  • Participate in Project Steering Committee (SteerCo) meetings.
  • Connecting Customers and Global Engineering:
  • Serve as the liaison between customers and the Global Engineering
  • structure.
  • Communicate customer requests to the engineering team.
  • Assist the engineering team in resource allocation, technology planning, and
  • high-level resource needs.
  • Relay project-related issues from Engineering to customers (Global
  • information).
  • Monitor and facilitate the handover process.
     

Experience and Knowledge requirement

  • Minimum 5 years in Infrastructure projects like Project Leader or Team Manager
  • Minimum 1 years within chemical, pharmaceutical or biotech company with minimum technical background (process and utilities).
  • People management with a minimum of 2 years in a Production/engineering environment as supervisor or manager.
  • Project management with a minimum of 5 capital projects succefully delivered and experience in capital project management up to min 10 mioEUR.
  • Experience in risk management (and related specific tools (FMEA, HAZOP)
  • Experience in capital and asset management is an asset.
  • Experience in Masterplan building
  • Fully fluent in English and French

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]

 

Quality Manager Voeding

  • Location: Hooglede
  • Job #24119

Quality Manager Voeding

Vast Contract – Regio Hooglede
#Quality#Management#Voeding

Beschik je over een Masterdiploma in een voeding gerelateerde richting?  Heb je enkele jaren relevante ervaring in kwaliteit in de voeding sector? Sta je sterk in je schoenen en ben je een echte people manager? Lees dan vooral verder!

Onze partner is op zoek naar een Quality Manager Voeding om hun kwaliteitsteam te versterken. Dit gerenommeerd productiebedrijf gelegen in regio Hooglede is internationaal actief binnen de voeding sector.
Jouw verantwoordelijkheden?

 

  • Je hebt de eindverantwoordelijkheid over de veiligheid voor de volledige site.
  • Je stuurt 2 kwaliteitsmedewerkers en 7 QC laboranten aan.
  • Je zorgt ervoor dat alle managers en mensen op de vloer kwaliteitsbewust te werk gaan en dat nieuwe regels correct geïmplementeerd worden.
  • Je analyseert klantenklachten en kwaliteitscontroles die fout gingen en maakt de nodige aanpassingen teneinde deze te voorkomen.
  • Je zorgt ervoor dat de site ten allen tijde aan de nodige kwaliteitsvereisten voldoet, o.a. met het oog op audits.
  • Je rapporteert aan de Plant Manager van de site en de Head Of Quality van de verschillende sites.
  • Je stelt specifieke werkinstructies op en houdt het kwaliteitshandboek up to date.

Wie ben je?

 

  • Je beschikt over een Masterdiploma in een voeding gerelateerde richting.
  • Je beschikt over enkele jaren relevante ervaring in kwaliteit in voeding.
  • Begrippen zoals HACCP, BRC en IFS zijn je niet vreemd.
  • Je staat sterk in je schoenen en kan mensen goed motiveren om de regels te volgen.
  • Je bent communicatief vaardig in het Nederlands, Engels en Frans. Notie Duits is een plus.
  • Je hebt een groot gevoel voor verantwoordelijkheid en bent een echte People Manager.

Wat kan je verwachten?

Als Quality Manager Voeding kom je terecht in een dynamische en open werkomgeving met aangename collega’s. Bovendien krijg je een mooie 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.

Voldoet deze functie aan jouw verwachtingen? Solliciteer dan rechtstreeks via de website of contacteer Sophie Carbonelle op het nummer +32 (0)498 52 10 53 of via sophie.carbonelle(@)jeffersonwells.be.
 

QA Officer Food

  • Location: Kortrijk
  • Job #24118

QA Officer Food

Vast Contract – Regio Kortrijk
#QA#Food#QC

Beschik je over een Bachelor of Master in een voeding gerelateerde richting?  Heb je een passie voor voeding en werk je zelfstandig? Ben je communicatief sterk in het Nederlands & Engels en spreek je een aardig mondje Frans? Lees dan vooral verder!

Onze partner is op zoek naar een QA Officer Food om hun kwaliteitsteam te versterken. Dit toonaangevend productiebedrijf gelegen in regio Kortrijk is wereldwijd actief binnen de voeding sector en staat bekend omwille van hun familiaal karakter.

Jouw verantwoordelijkheden?

Je job bestaat voor 80% uit QA-taken en voor 20% uit QC taken. Je takenpakket ziet er als volgt uit:

  • Je bent verantwoordelijk voor de klantenbehandeling. Je onderzoekt non-conformiteiten en klachten.
  • Je werkt hiervoor nauw samen met de verschillende afdelingen: sales, customer service, R&D,…
  • Je volgt data & trends op en houdt het kwaliteitshandboek op punt.
  • Je bereidt interne & externe audits voor.
  • Je zorgt ervoor dat de juiste kwaliteits- en veiligheidsregels gevolgd worden op de werkvloer & probeert deze steeds te verbeteren.
  • Je voert de nodige controles en testen uit om de kwaliteit van de grondstoffen en producten te evalueren.

Wie ben je?

 

  • Je beschikt over een Bachelor of Master in een voeding gerelateerde richting.
  • Begrippen als HACCP, GMP,… klinken je bekend in de oren.
  • Je bent communicatief sterk en beschikt over de nodige People skills.
  • Je bent zelfstandig en hebt een passie voor voeding.
  • Je bent communicatief vaardig in het Nederlands & Engels en hebt een gemiddelde kennis Frans.

Wat kan je verwachten?

Als QA Officer Food kom je terecht in een dynamische en open werkomgeving met aangename collega’s. Bovendien krijg je een mooie 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.

Voldoet deze functie aan jouw verwachtingen? Solliciteer dan rechtstreeks via de website of contacteer Sophie Carbonelle op het nummer +32 (0)498 52 10 53 of via sophie.carbonelle(@)jeffersonwells.be.
 

Construction Safety Coordinator – Senior

  • Location: Wavre
  • Job #24117

Construction Safety Coordinator – Senior
The mission
The construction EHS coordinator shall be a competent construction professional, responsible for checking that the project construction activities are executed safely in accordance with the company’s requirements.
What are the responsibilities?
• coordinate construction activities and liaise with the Host Site EHS team
• review safe methods of working ahead of work starting
• lead daily safe work planning sessions e.g. SPA, RAMS, PTW
• participate in daily prestart workforce safety briefings
• participate in safety meetings and lead daily safety walks of the site
• participate in toolbox talks
• assist in incident investigation
• induct / orientate the workers
• identify and control new workers
• identify general and specific safety hazards to the workers
• inspect and conduct safety audits of tasks and safe systems / processes
• ensure that all incidents are reported
• participate in incident investigations
• ensure workers only carry out tasks for which they are trained and qualified
• ensure risk assessments and method statements are in place and in use
• encourage and participate in the behavioural safety system
• intervene and correct any unsafe conditions
• participate in safety meetings
• ensure good housekeeping and organised tidiness (5S) at all times

Experience and Knowledge requirement
• Experince in construction management of medium and large capital projects
• EHS experience
Soft Skills:
• Project and people management skills with thorough knowledge of construction
• Communication and collaboration skills

Education, Methodology & Certification Requirements;
• University or college training in engineering or EHS
• Formal safety professional certification

ICT Skills (software, operating systems, hardware, etc.);
MS Office

Language Proficiency Requirements:
English – Business
French – Fluent

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]