Dissolution Scientist

  • Location: MECHELEN
  • Type: Contracting
  • Job #19786

Dissolution Scientist

Will you be our new ambassador?

Jefferson Wells Life Sciences specializes in supporting pharma & biotech companies in their daily challenges. Hence our interest in experts like you to join our team. 

Let's look together at your first challenge with us!

Job Description

As a Dissolution Scientist you will apply the latest scientific thinking in dissolution testing to help bringing new medication to patients worldwide.

  • You will the design, plan, follow up and coach dissolution work to help the development of the best possible dosage form for the patient.
  • You will take an active part to biopharmaceutical assessment strategy towards predicting in vivo exposure, to the improvement of biorelevant methods and to the development of clinically relevant QC methods and specifications.
  • You will contribute to the automation strategy within the team. You will contribute to a further mechanistic understanding of in vitro dissolution.
  • You will contribute to progress data modeling and analysis approaches.
  • You will participate to technical and strategical meetings with colleagues in Beerse or in different sites around the world,and will represent the Dissolution Sciences team in cross-functional matrix environment including formulation development, pharmaceutical sciences, clinical pharmacology, quality assurance and regulatory.
  • You will also be responsible for writing and review technical and scientific documents.

Profile 

  • You have a PHD or Master degree in Analytical Chemistry or Life Sciences related 
  • You have knowledge of pharmaceutical sciences relevant to the development of small molecule formulations, analytical chemistry, compliance and GMP.
  • You have experience with dissolution testing (QC and/or biorelevant) and dissolution method development is a plus.
  • You have experience in statistical or data modelling / DoE / MVA is a plus.
  • You have experience with laboratory automation is a plus.
  • You are a fast learner with scientific curiosity, self-steering, pro-active, creative.
  • You are open-minded, with ability to work together as one team in a global environment.
  • You have good presentation skills in scientific meetings.
  • You have a good written and spoken communication in English.
  • You have Knowledge of Dutch or willing to learn the basics.

 

What can Jefferson Wells do for you?

As an ambassador you have the opportunity to grow within international companies where you can build a strong network. Through a personal follow-up, you receive quality support in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal training and education.

 

Are you interested? Apply now!

Clinical Study Administrator

  • Location: DIEGEM
  • Type: Contracting
  • Job #19785

Will you be our new ambassador?

Jefferson Wells Life Sciences specializes in supporting pharma & biotech companies in their daily challenges. Hence our interest in experts like you to pass our team. 

Let's look together at your first challenge with us!

Clinical Study Administrator

In this role you will provide support to the clinical study staff within Clinical R&D, as well as foster strong, productive relationships with colleagues within the Clinical R&D Organization.

Location: Beerse

Scope of work:

  • Clinical Administration Tasks – (includes CTMS build and tracking, v-TMF build & upload)
  • Under general supervision, accountable for the timely tracking of study essential documents and ensuring completeness of data and documentation for assigned clinical studies according to appropriate regulations, departmental guidelines, and work instructions.
  • Creation/distribution of regulatory binders & the wet-ink signed documents binder
  • Assist study staff and investigators to quickly and effectively resolve issues relating to specific documentation.
  • Respond to problems and assists in implementing corrective and preventive actions.
  • Assist in providing internal communication of important clinical data and events.
  • Support ongoing use of CTMS by maintaining and tracking relevant activities.
  • Provide safety documentation to other functional groups in support of safety committee meetings as requested (supporting role).
  • May be asked to provide support for study supplies creation, ordering and distribution to the sites e.g. print protocols, burn DVDs
  • May be asked to assist with device tracking and ordering if required and if applicable.
  • Assistance with logistics for Investigator meetings/expert panel meetings
  • Assistance with distribution of clinical updates newsletter
  • Participates in process improvement activities related to CTMS/vTMF within the department.
  • May provide other administrative support for clinical study or departmental activities as needed and assigned by supervisor or study leaders

Who are you?

Must

  • You have a bachelor’s or equivalent amount of experience
  • You have at least 1 year of previous administrative support experience
  • You have knowledge of Excel, Word and Power Point
  • You are fluent in written and spoken Dutch and English
  • You are well-organized
  • You pay attention to details

Plus

  • Previous Clinical Research experience is a plus
  • You have at least 1 year of previous administrative support experience
  • Experience tracking client issues is a plus

 

What can Jefferson Wells do for you?

As an ambassador you have the opportunity to grow within international companies where you can build a strong network. Through a personal follow-up, you receive quality support in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal training and education. 

Site Manager

  • Location: Aalter
  • Type: Contracting
  • Job #19610

Jouw verantwoordelijkheden?

Als Site Supervisor ben je op de werf verantwoordelijk voor een correcte en tijdige uitvoering van jouw werken en het aansturen van je team.

  • Je voert de nodige ontwerptekeningen uit of laat je deze uitvoeren.
  • Je staat in voor de planning van het personeel, het te gebruiken materiaal, verdeling van de taken en opstelling van de installaties op de werf.
  • Je probeert tijdens het project steeds een correcte inschatting te maken van de middelen, alsook proactief optimalisaties voor te stellen.
  • Je staat mee in voor het opvolgen en naleven van de veiligheidsprocedures.
  • Je houdt rekening met de begroting betreffende het aantal aangewezen uren, de termijnen en de kwaliteit.
  • In jouw rol rapporteer je aan de Project Manager.

Wie ben je?

Om de rol van Site Supervisor goed in te vullen ben je in het bezit van een diploma Industrieel Ingenieur Elektromechanica of ben je gelijkwaardig door ervaring. Bij voorkeur heb je al ervaring opgebouwd in werfbeheer en bent een geboren leider. Daarnaast ben je communicatief met de nodige commerciële flair en klantgerichtheid. pakketten. Je kan je vlot uitdrukken in het Nederland en Engels.  

Aandacht voor veiligheid en werken volgens kwaliteitsprocedures zijn voor jou vanzelfsprekend!

Wat kan je verwachten?

Als Site Supervisor 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 kunnen in aanmerking komen. 

Voldoet deze functie aan jouw verwachtingen? Solliciteer dan rechtstreeks of contacteer Sara Van den Bossche op
het nummer +32 (0)4 72 79 10 42

Associate Scientist

  • Location: Mechelen
  • Type: Contracting
  • Job #19779

Will you be our new ambassador?

Jefferson Wells Life Sciences specializes in supporting pharma & biotech companies in their daily challenges. Hence our interest in experts like you to join our team. 

Let's look together at your first challenge with us!

Job Description

  • Execute experiments assisting the scientific experts, supporting the implementation of New Analytical Technologies and Process Analytical Technologies (PAT) for small molecule applications.
  • Execute Near-Infrared (NIR)/Raman method development, validation and transfer activities on small molecule projects related to lab applications (content uniformity, moisture, polymorphs and identification).
  • Execute data review
  • Author and review protocols and reports regarding method development, method validation and method transfer
  • Report results to teams and management.
  • Ensure high scientific quality standards for experiments and take on responsibility for these experiments.
  • Comply with regulatory, GMP and safety rules
  • Work in a multidisciplinary team​

Education & experience

  • You hold a Master degree in Analytical Chemistry, Pharmaceutical Technology or a related science with a minimum of 3 years of experience in a Pharmaceutical Company
  • Expertise in various spectroscopic techniques (NIR, Raman, UV and IR) for application in analytical chemistry is preferred.
  • Knowledge of statistical data analyses and chemometrics is beneficial.
  • Knowledge and/or experience with pharmaceutical processes (granulation, blending, spray drying, coating, …) and PAT tools is an asset.

Competencies

  • Ensure high scientific quality standards for experiments and take on responsibility for these experiments.
  • Efficient, flexible and dynamic.
  • Innovative solutions/technical skills.
  • Customer focus and results and performance driven.
  • Sense of Urgency.
  • Excellent communication skills.
  • You have a good knowledge of English, both spoken and written.
  • You are able to work independently, though you are also a team player.
  • Driving license is preferred

 

What can Jefferson Wells do for you?

As an ambassador you have the opportunity to grow within international companies where you can build a strong network. Through a personal follow-up, you receive quality support in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal training and education.

Are you interested? Apply now!

 

Quality Coordinator

  • Location: Sombreffe
  • Type: Contracting
  • Job #19777

QA Coordinator  

Namur – Contracting

What are your responsibilities?

  • Implement and maintain the ISO norm 17034 and ensure ad-hoc integration into existing quality system (ISO 9001, 17025) and initiating the strategy for improvement
  • Build and maintain documented quality standards and ensure full compliance for relevant products:
  1. Provide & maintain documented Q.C. procedures
  2. Ensure compliance to these procedures with concerned ISO norms
  3. Lead, execute internal/external audit processes and quality assurance program
  • In conjunction with stakeholders, drive accreditation & compliance to ISO 17034
  • Support the organization by providing Quality training/education and coaching
  • Advise and act as primary point of contact for all ISO17034 related aspects with Mgt, provide recommendations for key quality decisions

Who are you?

  • Master / Engineering Degree in chemistry, or equivalent status
  • At least 3 years of working experience in production and/or a quality assurance
  • Experience in project management (in cross functional teams)
  • Knowledge of internal organization and processes (production, marketing, supply chain, purchasing, QA, etc.)
  • Extensive knowledge of QA systems (ISO 9001, 17025)
  • Strong presentation skills and the ability to provide effective training
  • The holder will need to have good communications, reading and writing skills in French and in English
  • Experience in project management is an asset, participation in (or lead) the implementation of changes and being able to solve issues or to report them accordingly is a valuable experience
  • Strong planning and organizing ability, ability to balance multiple priorities
  • PC skills and be competent in Excel, Word, PowerPoint, etc.

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 invite you to apply!

QA Analyst

  • Location: DIEGEM
  • Type: Contracting
  • Job #19770

Will you be our new ambassador?

Jefferson Wells Life Sciences specializes in supporting pharma & biotech companies in their daily challenges. Hence our interest in experts like you to pass our team. 

Let's look together at your first challenge with us!

QA Analyst

In this role you report to the client Manager of Quality Strategy & Compliance EMEA.
Location: Diegem

Scope of work:

In this role you support the different health authority requirements associated to the derogations granted for the distribution of client products pending MDR certification, where the MDD certificate has expired. You’ll work in collaboration with supply chain and regulatory dedicated resources to ensure that the distribution processes are compliant and in line with HA requirements and that all commitments are being maintained.

Who are you?

  • A degree in Life Sciences or equivalent by experience
  • Understanding of Quality Management Systems (QMS)
  • Understanding of good manufacturing practices (GMP)
  • Experience in Compliance
  • Demonstrated Project Management skills
  • Understanding of complex supply chain
  • Experience with EU MDR (economic operators process & verification)
  • Team work, ability to influence and work with cross-functional teams

 

What can Jefferson Wells do for you?

As an ambassador you have the opportunity to grow within international companies where you can build a strong network. Through a personal follow-up, you receive quality support in every step that you accommodate. Finally, you enjoy the opportunity to develop yourself personally and professionally through internal training and education. 

Automation Engineer

  • Location: Wavre
  • Type: Contracting
  • Job #19761

Automation Engineer

Brabant-Wallon – contracting 

#GMP #SME

Our partner is looking for an Automation Engineer 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?

  • Support technically the global projects for upgrading different automation applications
    • The applications in scope are SCADA, Particles & Environment monitoring systems, Serialization & aggregation, Automatic backup & Versioning control.
  • Assess and study the install base of each application in scope of each project
  • Do the market analysis and benchmarking to identify the proper solution for each application
  • Collect system requirements involving different sites SME’s, challenge them for identifying new ways of working and seeking modernization of applications use
  • Build testing environment for the identified solution/s to properly test it
  • Work closely with the vendor of the solution to identify the proper design & architecture
  • Build the LDD (Landscape Definition Document) of the solution assuring highest redundancy and availability
  • Work with Tech (IT) to identify the proper build of the infrastructure to assure the proper management and maintenance of the application across its life cycle
  • Work with OT team to assure that OT controls and policies are properly considered in the design and development of the solution
  • Work with Data management team to assure the proper interfacing with Historian is considered
  • Participate in creating the system URS
  • Review the design specification documents (SDS, FDS, HDS, NDS, …etc.)
  • Review the related IT documents to the application (DRP, SP, …etc.)
  • Work with Automation CAPEX PMO to assure the proper planning and interdependency between different projects is well considered
  • Work with Automation CAPEX team to assure the proper execution of the projects
  • Identify and escalate any associated risk to project technical execution
  • Collaborate with sites automation teams during Project mode & BAU (Business as Usual)
  • Act as expert in his/her domain of competence

Who are you?

  • You hold a master's degree
  • You have at least 5 years of experience in a similar role in a GMP environment
  • You have good knowledge of OT Industrial automation Systems in general, in particular Wonderware Archestra, Siemens & Allen Bradley PLc’s
  • You have basic knowledge of EMS (Environment Monitoring System) & BMS (Building Management System)
  • You are fluent in English. French 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

Quality Assurance VQS

  • Location: Braine l'Alleud
  • Type: Contracting
  • Job #19748

Vendor Quality Support

Brabant Wallon – contracting

Our partner is looking for a Vendor Quality Support to reinforce its team. This international company is well-known for its research, development, and marketing of pharmaceutical and vaccines

What are your responsibilities?

  • Review annual stability protocol and reports. Communicate any trends to the Vendor Quality Lead (VQL).
  • Perform review of CMO PQR within agreed timeframe, complete PQR Assessment
  • Participate to Quality Agreements (QAA) periodic reviews and draft QAA according to available templates.
  • Perform stakeholder review of various change controls, support change control preparation, keeping change control trackers up to date accordingly.
  • In specific cases, review Validation and Technical Transfer protocols and reports liaising with VQL.
  • Review Master Batch records changes linked to change controls or to support initiation.
  • Investigations/deviations/ out-of-specifications. Perform the QA review of deviation notifications, retrieve and collect supportive information from involved stakeholders to allow and perform assessment.
  • If needed work with the Vendor Quality Lead, the Vendor team and Global Quality Lead to determine the Root cause of issues which may lead to a Technical meeting. Coordinate vendor quality related investigations.
  • Support Audits preparation at our partner or at the vendors
  • Support Risk based evaluation of the vendors in collaboration with VQLs.
  • Provide expert QA advice, support and management for technical operational QA and general QA matters associated with the assigned products and activities at the vendors.
  • Address CMO Connectivity Fail messages and coordinate resolution of issues internally and with appropriate vendors. Ensure regular update of relevant guidance.
  • Quality Complaints: Perform trend, recurrence analysis with the Central Complaint Unit, escalating issues to VQL.

Who are you?

  • You hold a bachelor’s degree (or master’s degree) in a Scientific orientation
  • You have 5 to 10 years professional experience & knowledge in a Quality role in the pharmaceutical industry preferably in the GMP operations environment
  • Hands-on field experience in failure investigations, root cause analysis, deviation review
  • Solid knowledge about European Good Manufacturing Practices (Eudralex Vol. 4)
  • You are fluent 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]

Quality Project Associate

  • Location: PUURS
  • Type: Contracting
  • Job #19766

Word jij onze nieuwe ambassador? 

Jefferson Wells Life Sciences is gespecialiseerd in de ondersteuning van farma & biotech bedrijven in hun dagelijkse uitdagingen. Vandaar onze interesse in experts zoals jij om ons team te versterken.

Laten we samen kijken naar jouw eerste challenge bij ons!

Quality project associate

Binnen een van de kwaliteitsafdelingen zijn we op zoek naar een Quality Project Associate. Dit departement zorgt ervoor dat de productie en testen op de site gekwalificeerd zijn en in compliancy met de wetgeving (GMP, ICH) en de juiste omschrijvingen heeft binnen de goedgekeurde registratie dossiers.
Locatie: Puurs

Belangrijkste taken in jouw rol zijn:

  • Uitvoeren van kwaliteitsreviews van validatiedocumentatie, change records en procedures
  • De regulatory impact van veranderingen onderzoeken
  • Ondersteuning bieden met regulatory submissies en responses
  • Ondersteuning bieden binnen de brede werking van het Quality Management System (validatie, QRM, Change Management, Regulatory System)

 

Your Profile:

Must

  • Master in wetenschappelijke richting of gelijkwaardig aan ervaring
  • Minstens een eerste werkervaring binnen de farmaceutische industrie is een must
  • Je hebt interesse in validatie, kwaliteitsbeweaking en het samenwerken met overheidsinstanties

Nice to have

  • Kennis van medicatiewetgeving is een troef (FDA, EMA)

Wat kan Jefferson Wells voor jou betekenen?

Als ambassador krijg je de kans om te groeien binnen internationale bedrijven waarin je een sterk netwerk kan opbouwen. Door een persoonlijke opvolging krijg je een kwaliteitsvolle ondersteuning in elke stap die je onderneemt. Tot slot geniet je van de mogelijkheid om jezelf persoonlijk en professioneel te ontwikkelen aan de hand van interne trainingen en opleidingen.

Heb je interesse in deze functie? Aarzel dan zeker niet en solliciteer nu met jouw cv!

Documentatie Ingenieur

  • Location: Kontich
  • Type: Contracting
  • Job #19587

Documentatie Ingenieur

Vast Contract  – Regio Halle
#Documentatie #industrialisatie #validatie

Beschikt je over een hoger technisch diploma, heb je kennis van documentatie technieken en gevoel voor mechanisch ontwerp? Op zoek naar een project waar deze technische kennis kan inzetten bij de ontwikkeling en de validatie van machines bestemd voor de pharma industrie? Dan is deze job zeker iets voor jou!

Voor een grote, internationale machinebouwer zijn we op zoek naar een enthousiaste documentatie ingenieur. Voel jij jezelf klaar voor deze uitdaging? Wil je samen met Jefferson Wells deze opdracht aangaan? Lees dan zeker verder!

Jouw verantwoordelijkheden?
 

Als Documentatie Ingenieur ben jij een cruciaal onderdeel van ons multidisciplinair team van ingenieurs en test engineers. Jouw job omvat: 

  • Schrijven van de technische documentatie b.v. handleidingen, werkinstructies, onderdelenlijst, …
  • Om documenten samen te stellen voor b.v. inbedrijfstelling, IQ, OQ, risicoanalyse, CSV, …
  • Opvolgen van de documentatie en validatie gerelateerde zaken in onze productie en op de locatie van de klant

Wie ben je?
 

Om de rol van documentatie ingenieur goed in te vullen, beschik je over een Bachelor in elektromechanica of ben je gelijkwaardig door ervaring. Je beschikt over een eerste werkervaring. Je bent een teamspeler met een passie voor machinebouw in al zijn facetten zowel mechanisch, elektrisch als software en procesmatige aspecten. Kwaliteit draag je hoog in het vaandel en bent klantgerichtheid met een accurate en analytische aanpak. Je kan je vlot uitdrukken in het Engels. Kennis van Nederlands is een plus.

Kennis in de farmaceutische industrie en in het bijzonder in GMP/GAMP is een troef.

Wat kan je verwachten?
 

Als documentatie ingenieur 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 kunnen in aanmerking komen. 

Voldoet deze vacature aan jouw verwachtingen? Aarzel dan niet om te solliciteren via de website of contacteer Sara Van den Bossche op het nummer (+32) 04 72 79 10 42 of stuur je CV naar [email protected]