QA Documentation Specialist

  • Location: RIXENSART
  • Type: Contracting
  • Job #19371

QA Documentation Specialist

Brabant-Wallon – contracting 

#GMP #QA #QMS

Our partner is looking for a QA Documentation Specialist to support their team. This international company is well known for the research, the development, and the commercialization of its pharmaceutical products.

What are your responsibilities?

As a GMP Compliance Officer you will Contribute to the management of our partner’s Global Quality System (Documentation) which is used by all Vaccines sites and throughout the Vaccines business. Here are your responsibilities:

  • Be able to guide/explain the Global Doc TeamSite (Refer to tuto’s, others Doc managers of MSAT, GENG,…).
  • Perform Compliance review activities (eg. Review of templates)
  • Support the global documentation network on creation of new ways of working upon migration to the new documentation system (review, support to design new processes)
  • Act as custodian of the global Doc communities (grant access, monitor the folders content) and support pre-migration activities (eg. enrichment)
  • Contribute to the creation of Global Written Standards on Vaccines level (job aid, wikis etc.)
  • Assess the fit for purpose documentation on an enterprise level and adapt based on Vaccines needs (documentation from GSC/ R&D etc.)
  • Provide training based on new defined documentation procedures

Who are you?

  • You hold a Scientific degree
  • First experience in in a similar position
  • Good knowledge of GMP and Quality Management System (QMS)
  • Good knowledge of GxP documentation activities
  • You are a good team player with communication skills
  • You are fluent in French and English

What can you expect?

Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. 

You’re interested in this job? We kindly invite you to apply. Do you have any questions? You can contact Sophie Rolis: [email protected] or +32497/51.50.92

 

 

 

Project Manager R&D

  • Location: RIXENSART
  • Type: Contracting
  • Job #19328

Project Manager R&D

Brabant-Wallon – contracting 

#GMP #PM #R&D

Our partner is looking for a Project Manager R&D to support their team. This international company is well known for the research, the development, and the commercialization of its pharmaceutical products.

What are your responsibilities?

As a Project Manager, you will plan and execute several projects in Microbiology Innovation and Modernization Initiative embedded in our partner’s strategy. This includes but is not limited to working with internal and external partners to plan, conduct and evaluate and implement technological solutions for QC Microbiology. Here are your main tasks:

  • Act as coordinator and project manager innovation projects.
  • CRO contract negotiation to execute the laboratory work incl. cost management.
  • Oversight laboratory work and interim progress evaluation (internal and external).
  • Draft and own study plans for internal approval and CRO approval
  • Sample organization incl. shipment and potential linked change control for sample management where required
  • Scientific evaluation of the study results
  • Conduct complex stakeholder management internally across sites and countries
  • Draft publication/position papers/guidance documents for the global QC department
  • Draft abstracts, posters, presentations for external advocacy on Microbiology Innovation.
  • Perform literature research and summarize in short briefings for scientists and senior management
  • Ensure documentation, minutes and reports are produced in a timely manner and are shred with major stakeholders and archived in line with the company requirements.

Who are you?

  • You hold a Scientific degree and have Analytical a background in Microbiology.
  • First experience in QC testing in GMP environments and/or validation of alternative microbiological methods (e.g. sterility, bioburden, endotoxin testing,…)
  • You are highly structured and organized with strong PM skills and scientific mindset
  • You are a good team player with communication skills and a diplomacy approach when dealing with colleagues within or outside the organization (in UK, Germany, Italy, US and Belgium).
  • You are fluent in English (any other language is a plus)

What can you expect?

Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. 

You’re interested in this job? We kindly invite you to apply. Do you have any questions? You can contact Sophie Rolis: [email protected] or +32497/51.50.92

 

 

 

Specialist QC Transfer

  • Location: RIXENSART
  • Type: Contracting
  • Job #18866

Specialist QC Transfer

Brabant Wallon – contracting 

#QC #Transfer #Pharma

Our partner is looking for a Specialist QC Transfer to join its team. This international company is well-known for its pharmaceuticals and vaccines. 

What are your responsibilities?

  • Execute the QC tests transfer activities according to SOP procedure between our partner’s sites in Europe
  • Draft, assign and support the following documents by co-building it with the experts, major stakeholder and if needed decision bodies; this includes the signature procedure:
  • Test Transfer Plan (TTP) at the beginning of a project, or when required.
  • Method Transfer Plans of the test transfer method protocols (via the AMTP/R (analytical method transfer protocol/report) process documentation).
  • Change request between sending and receiving sites
  • Use statistical tools and QC tests validation protocols/reports to:
  • define the tests transfer criteria, in collaboration with QC statisticians, QC coordinators (GQC) and QA colleagues
  • analyze the QC results obtained locally and write the AMTR (report) documents.
  • Support the training coordination between donor and receiving sites
  • Support the transfer strategy in resolving bottlenecks and showstoppers
  • Draft publication for replacement and reduction of animal testing scientific. Act as key contact for all involved parties related to Data work and review.
  • Draft abstracts, posters, presentations for external advocacy on the topic of replacement and reduction of animal testing.
  • Perform conclusive Literature research and summarize in short briefings for Scientists and Senior Leaders
  • Ensures documentation, minutes and reports are produced in a timely manner and are shred with major stakeholders and archived in line with the Company requirements.

Who are you?

  • You hold a Scientific master’s degree
  • You have minimum of 8 years of proven experience in setting up & leading successful method transfers within the pharmaceutical industry
  • You have Scientific and Analytical background of the “in vitro” and “in vivo” QC analytical methods
  • You are a good team player with communication skills and a diplomacy approach when dealing with colleagues within or outside the organization
  • Good written and oral presentation capability in English

What can you expect?

Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. 

You’re interested in this job? We kindly invite you to apply. Do you have any questions? You can contact Sophie Rolis: [email protected] or +32497/51.50.9

QA officer

  • Location: rixensart
  • Type: Contracting
  • Job #18538

QA officer

Brabant Wallon – contracting 

#QA #QC #Pharma

Notre partenaire est activement à la recherche d’un QA officer pour completer son équipe. Notre partenaire est une multinationale connue pour ses vaccins.

Quelles sont vos responsabilités?

Le domaine de cette activité de QA infrastructure du QC est très vaste et varié et concerne des équipements de laboratoire (HPLC, incubateurs, frigos…) et des équipements d'infrastructure (hottes à flux laminaire, autoclaves, clean utilities…). Voici quelques unes de vos tâches quotidiennes :

  • Réaliser les oversights sur notamment:
    • logbooks équipements
    • alarmes
    • suivi des clean utilities (WFI, ACP…)
    • work orders (dossiers "C&M")
    • activités de maintenance
    • activités de calibrage
  • Revoir et approuver :
    • les avis MO
    • les master data liés aux équipements
    • la création de spare parts
    • les plans dans SAP
    • les CAPA
    • protocoles SODEXO
    • des procédures locales (dans le scope de l'activité)
    • vérification du statut sec du matériel sortant de l'autoclave
    • vérification des schémas aérauliques statiques et dynamiques
  • Participer à certaines investigations approfondies liées à tous ces sujets
  • Travailler en collaboration étroite avec les clients opérationnels (services techniques maintenance Calibrage et Mesure) et avec les membres de l'équipe en interne

Qui êtes-vous?

  • Vous disposez d’un Bachelier ou équivalent par expérience
  • Vous avez une première expérience en environnement Pharmaceutique/Bio/Medical device
  • Vous maitrisez l’anglais (lecture et compréhension de procédures, check lists…)
  • Vous avez un esprit d’équipe, êtes orienté qualité et flexible.

Que pouvez-vous attendre?

Jefferson Wells vous propose un contrat à durée indéterminée en tant que consultant avec un package salarial attractif et vous donnera accès à des formations en matières techniques et soft skills. Nous serons votre partenaire de carrière pour chaque étape de votre chemin.

Cette offre vous intéresse ? Nous vous invitons à postuler. Si vous avez des questions, vous pouvez contacter Sophie Rolis : [email protected] ou +32(0)497/51.50.92

 

Maintenance Reliability Engineer

  • Location: RIXENSART
  • Type: Contracting
  • Job #18483

Maintenance Reliability Engineer

Brabant Wallon – Contracting 

The main purpose of the Industrial Method Engineer (IME) is to analyze the performance of the department in terms of safety, reliability, availability and maintenance costs.Working closely with the execution team and the engineers of several disciplines, it maintains and optimizes the technical performance in terms of reliability, safety and environmental integrity of the department.The IME develops, implements and manages preventive maintenance, inspections and revises plans. In addition, it provides support and technical support to ensure cost-effective solutions.

Your responsibilities ? 

  • Define & implement Visual Management on packaging lines;
  • Support the implementation of the Quick wins related to the new maintenance strategy;
  • Support the technical team in order to solve recurrent technical issue thanks to root cause analysis (RCA – DMAIC) approach and presence on the shop floor;
  • Implementation and follow-up of the findings related to the problem-solving exercises;
  • The facilitation of the work process to assure that we are identifying, prioritizing, and mitigating reliability threats;
  • In charge of "quick-wins" project from the definition to the implementation;
  • The facilitation of workshops is required;
  • The assessment of bad-actors in terms of performance and reliability on packaging lines;
  • Support team in charge of technical improvements on the shop floor;
  • Providing regular communications and status reports to your hierarchy.

Your profile? 

  • Minimum 3 years of proven experience in Industrial Method or Reliability Engineering roles
  • Fluent in French and English, both written and spoken (must-have for the role)
  • Strong experience in industrial Visual Management
  • Experience with LEAN manufacturing tools like Green or Black Belt certifications
  • Sound knowledge in "condition-based performance monitoring systems"
  • Comfortable with database management and processing
  • Good judgment to set priorities
  • Result-oriented
  • Proactive
  • Work under pressure, analytical, solve challenges, give support and make decisions.
     

Our offer ? 

We offer you a permanent contract and an attractive salary package. You will also have the opportunity to develop personally and professionally through internal training.

If you are interested, don't wait any longer!

Apply directly via our website WWW.JEFFERSONWELLS.BE or send your CV to the following email address [email protected]

Technical Regulatory Writer

  • Location: RIXENSART
  • Type: Contracting
  • Job #18472

Technical Regulatory Writer

Walloon Brabant – Contracting

#RA #Pharma #CMC

Our partner is currently looking for a Technical Regulatory Writer to reinforce its teams. Our partner is a pharmaceutical company.

What are your responsibilities?

The Technical Regulatory Writer is involved in the company’s regulatory activities related to new & existing products, on a domestic or international basis. Activities focus on technical writing for Facilities, major and minor submissions. Here are your main tasks:

  • Write CMC, “facility and equipment” parts and new files for WW regulatory File.
  • Manage and schedule with SMEs and Site conformance (and Production, Validation and Quality Assurance) the writing/review process to ensure timely completion.
  • Ensure the coordination with the departments involved in the writing/review process
  • Write and support regulatory affairs responses to questions raised by Regulatory Authorities
  • Monitor that supportive data provided by other departments are compliant.
  • Report significant issues
  • Assess the change controls that relate to pure facilities and equipment matters or work with GRL teams for change controls impacting both CMC and facilities.

Who are you?

  • You hold a master’s degree (in Life Sciences) or equivalent by experience
  • You have a first experience in writing CMC (technical) parts of regulatory documents (registration files or variations).
  • You have good Knowledge of biologic process and process equipment.;
  • You have good communication and writing skills
  • You are fluent (both written and spoken) 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]

Supply Planner

  • Location: RIXENSART
  • Type: Contracting
  • Job #17830

Supply Planner

Brabant Wallon – contracting 

#SupplyChain #SAP #APO

Our partner is looking for a Supply Planner to join its team. This international company is well-known for its pharmaceuticals and vaccines. 

What are your responsibilities?

  • Delivering production plans for a product/franchise on a monthly basis at SKU level (in APO). Manage all planning master data & parameters to allow automatic use of system (APO optimizer).
  • Provide visibility of End to End status across a product/franchise, manage risks & opportunities.
  • Ensures Bulk and Fill plans can fulfill packaging and Customer Demand.
  • Prepare scenarios in case supply issue occur and/or manage all constraints (Regulatory Affairs, life-cycle management, Quality)
  • Be the contact person to other stakeholders in the organization (Regulatory, Quality, Manufacturing Strategy, Technical life cycle Management, central planning, Global Product Leads..)
  • Manage product inventory (vs target) and monitor product performance (master data, inventory, leadtime)
  • Reflect customer demand in APO

Who are you?

  • You hold a bachelor’s degree and a Supply Chain certification is a plus.
  • You have 3 years of planning experience in a complex organization
  • You have good knowledge of SAP/APO
  • You are a team player and autonomous
  • 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] or +32497/51.50.92

QA Validation

  • Location: rixensart
  • Type: Contracting
  • Job #18471

QA Validation

Brabant Wallon – contracting 

#Pharma #QC #QA

Our partner is looking for an QA Validation to join its team. This international company is well-known for its pharmaceuticals and vaccines. 

What are your responsibilities?

  • Approve the validation documentation regarding the GMP requirements and the company’s procedures for validation protocols and reports (IMPQ) for new building & new equipment but also for routine validation & periodic review.
  • Approve the qualification documentation regarding the GMP requirements and the company’s procedures.
  • Review and approve equipment lifecycle (URS, master data, calibration status, qualification, …)
  • Review and approve documentation related to the validation / qualification executed.
  • Provide a compliance expertise during use and development of validation/qualification strategies.
  • Identify and escalade to his management all potential deviations.
  • Review and challenge the validation/qualification deviations (except product impact) and CAPA.
  • Ensure and manage the implementation of CAPA
  • Review SOP related to its M&CS department in accordance with validations, procedures and timelines.
  • Perform QA on the floor
  • Report any major event to its QA management

Who are you?

  • You hold a master’s degree in a general Science or Life Science Degree (Pharmacy, Chemistry, Bio Engineer, Biology, Biomedical Sciences).
  • You have a first experience in Validation or QA validation within biopharmaceutical industry
  • You have good knowledge of current good manufacturing practices in biopharmaceuticals and validation processes
  • You are fluent in English (both written and spoken)

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

Deviation & CAPA Specialist

  • Location: RIXENSART
  • Type: Contracting
  • Job #18408

Deviation & CAPA Specialist

Walloon Brabant – Contracting

Our partner is looking for a Deviation & CAPA Consultant to join its team. This international company is well-known for its pharmaceuticals and vaccines.

What are your responsibilities?

  • Manage and Coordinate Process/Product activities related to Deviation and CAPA Quality Systems
  • Manage and Coordinate Process/ Product deliverables expected trough the CAPA/DEV Systems
  • Contribute to decrease in the number deviations and CAPA of the unit.
  • Manage process & product trend analysis and quality reviews on the CPV system (Process Robustness Follow-up)
  • Ensure that major issues with impact on Process/Product are captured, followed up and treated in the manufacturing unit action plans.

Who are you?

  • University degree in Science (Pharmacist, Engineer or equivalent)
  • Former relevant industrial experience or equivalent in pharmaceutical Prod., Valid. or QA in a biopharmaceutical.
  • A previous experience in a QA department is a real asset.
  • Relevant experience in GMP
  • Problem solving and achievement oriented
  • Team spirit

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.

Engineer Project Coordinator

  • Location: RIXENSART
  • Type: Contracting
  • Job #18351

Engineer Project Coordinator

Brabant Wallon – Contracting 

#Pharma #SAP #Calibration

Our partner is looking for an Engineer Project Coordinator to join its team. This international company is well-known for its pharmaceuticals and vaccines. 

What are your responsibilities?

You will assist a project manager, from Scheme to Handover & Close-out to assure an outcome which meets all of the defined project objectives for cost, schedule, quality (fit for purpose) & safety and delivers the business benefits for the following global projects.

Here are your main tasks :

  • Calibration Checklist Digitalization project (Optimize calibration execution by developing digital checklist in SAP – simplifying vaccines sites calibration result encoding in SAP)
  • Data Driven Calibration Optimization project (The goal is to develop and implement a frequency optimization tool to optimize calibration frequency across vaccines sites)
  • Master data optimization project (project goal is to implement digital BOTs (Build Operate Transfer) automates to optimize master data encoding in SAP across vaccines sites.)
  • Monitoring and update of project schedule
  • Organizing workshops, Kaizen, trainings…
  • Management of meetings and minutes of meeting
  • Ensuring organization and attended to project review meetings
  • Manage Project documentation
  • Follow-up of the communication plan
  • Supporting stakeholder management
  • Support during implementation and optimization roll out
  • Performing REX and project close-up

Who are you?

  • You hold an engineering master’s degree
  • You have minimum of 3 years of proven experience in setting up & leading project within pharmaceutical industry (GMP)
  • You have ICT Skills (software, operating systems, hardware, SAP, etc.)
  • You have an experience with stakeholder management
  • You are :  results driven, deal with complexity and uncertainty, good communicator and able to adapt to audience
  • You are fluent in French and 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 Marie Rossenfosse : [email protected] or +32 494/91.87.40