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.
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!
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.
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]
Scientist, Injectable Drug Product Process Development
Walloon Brabant – Contracting
Major Responsibilities
Design and execution of lab studies in relation to drug product development activities, capture and analyze data and author related documentation (write-ups, protocols, reports (e.g. filter selection and sizing, target fill volume assessment, compatibility assessments, clinical blinding, etc.) ;
Capture and analyze critical manufacturing process data for process understanding and process characterization ;
Perform process risk assessments ;
Design DP processes for sterile injectable drug products in liquid or lyophilized powder form, in vials, pre-filled syringes or as combination products) ;
Define the investigational medicine product preparation process in clinical trials ;
Provide support to ensure timely manufacture of stability and clinical DP batches ;
Provide support to process performance qualification/validation Ensure products are manufactured in accordance with the client's quality system, cGMP and latest regulatory requirements ;
Provide support in the completion of the relevant sections of the CMC regulatory submissions and regulatory briefing documents and response to questions from authorities ;
Provide support in investigations of deviations and complaints related to DP quality ;
Support knowledge transfer from late phase development to commercial for validated DP processes ;
Contribute to develop the ways of working in the department.
Profile
Bachelor's Degree ;
2–3 years of experience in manufacturing or production support ;
Knowledge of fill & finish processes (even indirect) ;
Ability to work independently after a few months ;
Scientific critical thinking ;
Clear and transparent communication ;
Motivation and energy ;
Fluent English (documents, meetings, interactions) ;
Scientist grade.
Nice to Have:
Experience with syringes or injectable liquids ;
Experience working with CMOs ;
Understanding of fill & finish steps and their impact on the product ;
Ability to translate needs into lab language/protocols ;
Experience writing scientific reports.
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]
Develop and maintain automation documentation and software for all assets lifecycle ;
Attend to workshops to ensure alignment with the different companies and disciplines ;
Participate to the overall automation strategy ;
Follow ‘up Automation Integrator and Vendor Packages during development and execution ;
Put in place strong collaboration with manufacturing entities to deliver strong support and expertise ;
Verify Automation Integrators deliverables and anticipate any cost increase ;
Attend to FAT / SAT / commissioning / Validation ;
Ensure automation deliverables follow GMP and HSE regulations ;
Proactively report and manage risks ;
Review verification protocols ;
Be part for 24/7 guard support in hybrid model with Automation Integrators (L1/L2) ;
Organize operator training ;
Perform handover to operation and support team ;
Manage punch list related to its packages / buildings.
Profil
Master's Degree
5 years in Engineering projects in Process Automation
Proven involvement in significant engineering projects, including risk/mitigation management ;
Good level of French and English ;
Strong knowledge of AVEVA System Platform (SP), OMI and RM with hands-on experience in troubleshooting and production support ;
Strong knowledge of SSMS (SQL Server Management Studio) for troubleshooting, running queries to extract and analyze data for investigations ;
Basic knowledge of SSRS (SQL Server Reporting Services) applied to designing, maintaining and troubleshootings generation of reports for operational needs ;
Basic knowledge of Aler AMS application with experience in configuring and monitoring the system for production support ;
Strong knowledge in design, execution and C&V ;
Ability to translate and present expert concerns to facilitate decision ;
Ability to work in highly dynamic environment and to handle challenging situations ;
High communication skills (leadership, negotiation, change management, facilitation) ;
Able to reach team decision and high sense of responsibility ;
Ability to challenge and argument ;
Ready to travel a limited period of time ;
Nice to Have:
IT knowledge (network, PC management) ;
Ability to communicate with IT ;
Pharma experience ;
Awareness of quality/regulatory requirements.
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]
Assist to Kick-off meetings, prepare and present sourcing approach.
Lead/participate/coordinate Procurement Packages activities in collaboration with Project team.
Handle full RFI / RFQ processes as appropriate as per Procurement Plan.
Organize presentation of offers and perform commercial analysis of bids (Total Value of Ownership optimization, business cases comparison).
In collaboration with the legal department, set up contractual agreements ensuring appropriate company protection (risk analysis – KPI setting).
Negotiate terms & conditions with suppliers.
Decide on vendor shortlist for negotiation, prepare and communicate award decision.
Consider sustainability criteria to ensure that the products and services purchased have the lowest environmental (during their entire life cycle) and most positive social (child labor provision, occupational health and safety, regulatory compliance) impact.
Communicate progress and prepare appropriate reports as needed by Project leads, Owner’s Rep, etc.
Manage Contract Execution (if required by the project)
Manage suppliers contractual and commercial relationship to meet main project drivers and secure project quality, the budget and the schedule by:
Supporting the project team as soon as potential issues arise and entering proactively into discussions with key partners.
Following up and negotiating changes of scope, including contract amendments.
Reporting on a weekly basis procurement status to the Project Manager and Engineering Lead.
Preparing and leading regular governance calls with the main suppliers.
Approving contractual milestones payment release.
Handling provisional acceptance and close out of accounts with suppliers.
Ensure consistency and adequacy of documents such as Performance Bonds, Bank guarantees, Invoices, confidentiality agreements.
Report packages status to the company Category Lead and to Project Management, as required, highlighting progress and areas of concern.
Track savings versus set targets and complies with reporting guidelines.
Comply with the company and project strategy, procedures, guidelines and software usage.
Your profile:
Minimum 3 years required
Experience in procurement and contract negotiation
Proven success in CAPEX projects (up to €50M) – Process EQUIPMENT.
Bachelor's degree minimum
Strong communication and stakeholder management skills
Ability to deploy standard processes and solve problems
Comfortable in technical and industrial environments
Fluent in both French and English
Nice to Have : Experience in Pharma industry
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]
Laboratory work and writing of methods and protocols.
Use of analytical techniques: chromatography (size exclusion, reverse phase, affinity, ion exchange, HILIC, HIC), capillary electrophoresis (CGE, CzE, iCE, MauriCE).
Collaboration with the team for theoretical and practical training.
Communication with the company contact point, planning, and technical experts.
Development, validation, and transfer of methods.
Design of experiments.
Autonomous management of laboratory activities related to method development, validation, and transfer.
Contribution to release and stability testing according to project needs.
Preparation, review, and approval of documentation (procedures, protocols, reports).
Analysis and verification of results.
Presentation and discussion of results in project team meetings.
Compliance with GMP/HSE rules and regulatory requirements according to product development phases.
Your profile:
3-5 years of experience in the pharmaceutical industry.
Good knowledge of protein chemistry.
Expertise in at least one analytical technique (chromatography or capillary electrophoresis).
Knowledge of Empower software.
Written and spoken French, written English.
Understanding of the principles behind the methods (not just execution).
Expertise in analytical method development and validation.
Ability to author and review comprehensive and accurate procedures, protocols, and reports.
Nice to Have:
Experience in biochemistry and separation of biological matrices.
Knowledge of separation techniques applied to proteins.
QC experience with understanding of methods.
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]
Execute technology transfer and upscale projects, in close collaboration with the company cross-functional teams (MSAT, External Manufacturing, Industrial & Analytical Leads, Quality, Regulatory etc.) and CMO.
Depending on the type of project, act as project manager or project team member.
Review and approve all project documentation (protocols, reports, risk assessments, forms,…)
Regularly track the project’s progress (timing, activities, resources, costs) against the plan and adjust as needed
Collaborate with the Quality team to ensure product quality and consistency, and manage deviations and change controls
Ensure manufacturing processes comply with regulatory requirements and industry standards
Edit CPV reports for the company products manufactured at the CMO and tested by the company
Participate in projects (upscale, technology transfer): assist to internal and external meetings, review/approve project documentation, manage deviations and change controls, report project progress internally
Provide the technical expertise to support the company’s CMO to ensure effective processes
Implement project management best practices throughout the project
Your profile:
Master’s degree in engineering, Pharmaceutical Sciences, or a related field.
Minimum of 5 years of experience in pharmaceutical manufacturing processes.
Technical and industrial expertise in sterile pharmaceutical products.
Experience in managing technology transfers.
Experience with compliance in a GMP environment.
Experience in project management
Fluent in French & English (written and spoken)
Subject matter expert in technical / manufacturing aspects related to sterile DP compounding and filling activities
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]
External Operations Quality Partner Brabant Wallon – Contracting What are your responsibilities?
Batch record review and administrative support (e.g., updating CoC, handling deviations, complaints, temperature excursions).
Provide timely and efficient GMP/GDP IMP Release function to all relevant internal project activities related to the development of the pipeline projects
Support compliance with all relevant and appropriate regulations and guidelines, such as those relating to GMP/GDP, health and safety, etc..
Support the systems and processes in place for the appropriate documentation of internal development activities and to maintain them in a manner compliant with regulatory and corporate requirements.
Ensure the Clinical Supply Quality activities are consistent across the range of different environments and teams supported (Vendors / Suppliers / in house).
Proactively support the activities of Clinical supply for relevant manufacturing quality systems (deviation close out / Change management / complaints / quality improvement).
Identify and facilitate resolution of technical and manufacturing quality issues that may impact the quality of the CMC sections of regulatory submissions.
Provide support in the evaluation of Temperature excursions for IMP.
Management of Quality Complaints of IMP.
Ensure active participation in the selection, evaluation, approval and maintenance of Vendors for IMP activities, including leadership or support to conduct appropriate audits.
Oversight of Distribution activities (deviations, Business Review Meetings, assessments, etc…)
Ensure CMO (packaging and distribution vendors) quality documentation is accurate and up-to-date, by editing and reviewing quality agreements
Contribute the preparation of audits (internal/external, regulatory inspections)
Lead internal audits / Self-Inspections
Who are you?
5 years’ experience in QA/compliance experience in pharmaceutical regulated environment
Good knowledge of cGMP and relevant regulatory requirements (e.g US, European, Japanese)
Strong experience in batch review.
Quality mindset with a pragmatic and proactive approach.
Fluent in English is a must and French is a nice to have.
Experience working with CMOs and vendors.
Familiarity with GMP and GDP standards.
Experience with quality systems (deviation management, complaints, change control)
Familiarity with clinical packaging environments (vs. commercial) is a plus
Certified auditor status is a plus.
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!
Ensure the organization, maintenance and lifecycle management of controlled documents and training materials
Ensure compliance with applicable regulatory frameworks (GLP, GCP, Research Guidance, HTA, HBS, HSE, etc.) and internal standards
Process harmonization and continuous improvement
Support the design and implementation of streamlined, harmonized processes that integrate documentation and learning activities
Contribute to continuous improvement initiatives aimed at enhancing efficiency, simplification, compliance and user experience
Promote best practices and innovative solutions in documentation and learning management, fostering a harmonized, customer-focused, and outcome-driven culture
Act as the coordinator for the Regulated/Non-Regulated/Controlled Document management system, ensuring timely tracking, updates, reviews, and approvals of SOPs, guidance and related documents (based on regulatory changes, SME inputs, inspection finding or scheduled reviews)
Provide expert guidance to document owners and Patient Solutions staff on controlled document management best practices.
Ensure effective training and communication related to new or revised SOPs & associated documents, including timely withdrawal of obsolete documents
Training coordination
Support Patient Solutions employees and managers in meeting training requirements by maintaining accurate training plans, curricula and matrices
Ensure the availability and accessibility of training materials linked to controlled documents impacting Patient Solutions
Collaborate with the department learning lead and line managers to develop and maintain relevant training programs (plans, matrices, …).
Manage training records and documentation, including CVs, job descriptions, attendance logs, training registers, ….
Stakeholder engagement and support:
Serve as a key point of contact for all Learning & Documentation-related questions.
Manage and respond to requests received, including through the global PSol Learning & Documentation mailbox.
Audit & Inspection Readiness
Ensure operational readiness for internal and external inspections and audits related to documentation and learning.
Track and follow up on actions resulting from audit or inspection findings.
Performance Monitoring & Reporting
Collect, consolidate, and report key performance indicators and metrics related to documentation and training compliance.
Maintain and update the Learning & Documentation compliance dashboard.
Additional operational support
Provide support as needed to the Head of Internal Coordination, Learning & Sustainability Compliance in managing and reporting on broader initiatives, including sustainability, compliance, communication, intranet content, PMO dashboards, and objective tracking
Who are you?
Relevant experience in GxP (GLP, GCP) regulations and within the pharmaceutical industry
Relevant experience in SOP /training and content management systems
Familiar with electronic document management systems (e.g., Veeva, SharePoint, or similar platforms) and Learning Management Systems (LMS) for training assignment, tracking, and reporting.
Languages skills: French and English
Proficiency in Microsoft Office suite (Word, Excel, PowerPoint)
Ability to collect, analyze, and develop visual reports, KPIs and compliance metrics.
Experience in dashboard creation and, potentially, in the use of communication tools
Detail-oriented with the ability to maintain a high-level perspective
Strong organizational, planning and coordination skills, with the ability to prioritize tasks, manage multiple responsibilities, and proactively adapt in an evolving environment
Ability to interact and collaborate with cross-functional teams and various stakeholders
Analytical mind, ability to make improvement suggestions and resolving issues
Project management and influencing skills
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.
HSE Compliance Officer We are looking for a motivated and experienced individual to join our team in the local support department in Belgium, within the Health, Safety, and Environment (HSE) service. Although the role touches on health and safety, it focuses primarily on environmental aspects. The position involves working on environmental projects and maintaining regulatory compliance across multiple regions (Wallonia, Brussels, Flanders).
The person will be responsible for managing environmental issues, including the “Licence to Operate” for our sites in HQ, Leuven, and Braine, in relation to environmental and urban planning permits. The individual will closely collaborate with the engineering team to ensure the necessary permits are obtained.
The Responsibilities
– Environmental Permits Management (Licence to Operate): Preparation, modeling, and data collection for the environmental and urban planning permits required for site activities – Regulatory Compliance: Ensure compliance of installations with legal health, safety, and environmental requirements, especially regarding the risks associated with the storage of hazardous materials (CVZO). – Environmental Projects: Track and manage environmental projects, including internal audits, measurement campaigns, and reporting to authorities. – Environmental Management System: Maintain and improve our certified environmental management system. Participate in internal audits, measurement campaigns, and manage the administrative data related to environmental services. – External Collaboration: Work with external consultants and experts to ensure effective environmental management and smooth communication with local authorities.
Skills and Knowledge Requirements
– Scientific Background: Degree in a scientific field with a specialization or relevant experience in environmental management. – Environmental Management Experience: Experience in managing environmental issues, with good knowledge of local regulations (Wallonia, Brussels, Flanders). – Administrative Knowledge: Ability to understand and follow environmental regulatory requirements and perform necessary reporting. – Legislation Knowledge: Knowledge of environmental legislation in Belgium (Wallonia, Brussels, Flanders) is an asset. – Languages: English is not required, but knowledge of Dutch is a plus, particularly for the Leuven site. – ISO Certifications: Experience in an environment with a certified environmental management system (ISO 14001) is an asset but not a requirement. – Flexible Working Hours: This position is a 50% replacement for the sick expert, with flexible hours (Tuesday, Wednesday, and Thursday mornings). – Remote work is permitted when on-site presence is not required, but there are no fixed remote work days. Additional Assets: – Experience with Seveso risk management (hazardous materials storage). – GMP (Good Manufacturing Practices) certification is a plus, but not required. – Ability to ask questions and solve problems independently.
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]
