Our partner is looking for a GlobalQuality Specialist to reinforce its teams and assist with delivery of the risk-based audit program by acting as the central point of contact for the audit management tool and offering expert support for inputs (associated with Audits and Inspections), outputs (for the Pharmacovigilance System Master File when applicable), and overall general support to the Quality Auditing & Compliance team on data and processes across the regulated GxP environment.
Your responsibilities?
Acts as main point of contact in Quality Auditing & Compliance team for the audit management tool.
Makes extractions from the audit management tool for data inclusion within internal reports as well as to meet Health Authority requirements
Develops, prepares and improve KPIs/metrics on performance.
Support the development and maintenance of training matrix for Quality Auditing & Compliance team.
Support the maintenance of Quality Auditing & Compliance team's controlled documents.
Support the execution of the audit Risk Assessment by contributing to data collection and maintenance.
Performs quality control checks on extracts from audit management tool for associate initiatives (e.g. PV Compliance Dashboard, audit and inspection data report).
Maintains listings of global health authority inspections for the purpose of renewals.
Supports the execution of the risk based audit programs through ensuring audit program listings are up to date.
Maintains the departmental mailbox.
Participates as required to the weekly audit scheduling meeting.
Supports the GxP QMS/eQMS audit process harmonization and maintenance across Quality Auditing & Compliance team.
Supports auditors with auditing and inspection activities from technologies and digitalization perspective.
Develops and/or updates processes associated with main responsibilities.
Participates in projects within competence.
Upon the request of/with the approval of the Head of Quality Auditing & Compliance CoE
Your profile?
Bachelor/Master in Life Science, Computer Science Degree.
3 years’ experience in the pharmaceutical/biotechnology area and/or Quality-related areas.
Experience in the pharmaceutical industry within regulated areas (e.g., Research, Laboratory, Clinical, Pharmacovigilance, Manufacturing, …) and/or Quality Assurance expertise is a plus.
Experience with Cognos, Veeva Systems, and/or Sparta’s TrackWise is preferred.
Fluent in computerized systems ; making extractions from systems to prepare listings and metrics. Experience with data migrations is preferred.
Familiarity with GxP systems in the pharmaceutical industry and of applicable regulations, computerized system validation, GXP principles, and practice. Able to apply theoretical knowledge in practical situations.
Familiarity with statistical principles, quality principles and data integrity principles.
Familiarity with Drug Substance and/or Drug Product manufacturing production processes and related Quality Systems.
Mind-set to understand Compliance and Regulatory issues.
Fluent in written and spoken English
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.
Our partner is looking for a Energy & Utilities Early Design Engineer to reinforce its teams. Our partner is a well-known pharmaceutical industry.
Your responsibilities?
The Energy & Utilities Early Design Engineer is responsible for carrying out feasibility studies of Energy and utilities projects within Sites & Infrastructure Investment Strategy & Early Design Department and more particularly for the energy and utilities projects:
Consolidates the ideation of the energy and utilities projects:
-Prepares and present scenarios to management for strategic decisions. -Delivers Feasibility and Early Design: user requirement brief, technical deliverables, budget, schedule, risks, alternative, prioritization -Transfers the feasibilities to the Delivery department in compliance with the governance
Assists the Sites & Infrastructure Partner, mainly in the field of energy and utilities: – Collecting user and site requirements – Completing the Project Ranking Forms – Establishing the project portfolio in the form of an investment plan – Contributes to the implementation of the Sites Master Plan
Propose technical solutions in order to: – 2030 environmental objectives: carbon neutral &reducing our water consumption by 20%. – Guarantee the necessary energy supplies – Optimize the Sites Utilities equipment’s and networks
Connect with his peers to have a deep understanding of the different Masterplans (Networks, Manufacturing, Laboratories…)
Your profile ?
Minimum 10 years in Infrastructure and Utilities projects like Project Leader or equivalent
Minimum 2 years within chemical, pharmaceutical or biotech company with technical background (Energy, Utilities)
Experience in capital and asset management
Experience in Masterplan building
Fluent in French and English.
Expertise in cGMP, Green and HSE standards
Expertise in chemical and pharmaceutical standards
Good financial background, especially in depreciation management.
Fundamentals in people management (incl change, decisions, conflicts, coaching, leading, etc…)
Background and experience with risk management.
Very good communication skill
Good analytical impact on the business/legal rules.
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.
Our client is looking for a LIMS Support Specialist to reinforce its teams. Our client is a well-known pharmaceutical industry.
What are your responsibilities?
As a LIMS Support Specialist, your main tasks will be:
Main activity: ensure Labware LIMS static data readiness in support to a project:
Configuration and qualification of all products & material analytical specifications and related analyses.
Configuration and qualification of environmental monitoring, sampling plans, configurations IPC related to a project.
Secondary activity: support to operational activities of the LIMS partner team:
Analysis of incidents related to LIMS sent by QC / DEV laboratories
Search and identification of root cause and proposal of solution to avoid reoccurrence (both from a process and technical point of view).
Determine whether an incident need to be resolved by the LIMS admin or by the IT team.
Implement changes not requiring a static data qualification.
Transfer incidents to the IT team.
Test solutions implemented by IT.
Participate the weekly follow-up meeting with IT LIMS team.
Support end-users on specific requests (e.g. data extraction, implement queries in the LIMS).
Manage access to LIMS system.
Who are you?
Bachelor / Master (preferred) in Sciences (chemistry / biology)
Mandatory strong knowledge of static data configuration of the Labware LIMS system (analytical specifications, analyses, In Process Control)
Strong knowledge of the QC laboratory analytical activities to fully understand the static data requirements
Knowledge of data management and relational DB (ability to query DB in SQL is an asset).
Ability to communicate in English with both IT and Business Departments.
Ability to follow several activities in parallel.
Ability to work in partnership with several departments.
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.
Our partner is looking for a Document Management Specialist to contribute to the effectiveness and efficiency of its team and the optimization of the quality of Client’s Study Document Management and Biological Sample Operations business processes. He will support Client’s user community and contribute to the continuous improvement of our business processes. This international company is well-known for its pharmaceuticals.
What are your responsibilities?
Study Documentation Operational Management – Manage day-to-day operations of regulated and non-regulated documents, this includes:
Records/Workflow/Template management, Technical Support (QC formatting in accordance with Client’s Writing Styles and publishing, and formatting standards for regulatory submissions), act as an ECMS (Electronic Content Management System) Business Administrator
Provide support and training to in scope users on e-content management systems and related business procedures and coordinate HBS requests and HBS orders according to users’ needs
Develop/update business documentation
Quality Control:
Newly implemented and in routine processes to ensure compliance and consistency
In collaboration with the Client’s Biobank Delegate, ensure that the tools for the inventory, tracking and storage of HBS comply with the operational standards for the acquisition, use, destruction, transfer, and storage of HBS
CoordinateBusiness Process Improvement (BPI) initiatives in order to streamline, simplify, standardize e-content management and Human Biological Samples (HBS) Biobank processes
Reporting: run and evaluate data reports, provide metrics and KPI’s for both study document management and HBS Biobank activities
Who are you ?
Experience of working in pharma industry, knowledge of pharmaceutical development processes, conduct of non-clinical studies and scientific deliverables
Scientific background
Proven experience under GxP (GLP, GCP) regulations
Proven experience in database management, ECMS (Electronic Content Management Systems, e.g. Veeva Vault)
Experience with HBS biobanking database is an asset
Experience in project coordination/management, any project management certificate is an asset
Priority management, ability to work on multiple objectives
Analytical, sequential and process compliance minded, attention to detail
Service management, demonstrate creative problem-solving skills to find effective solutions
Customer and quality focused
Ability to work alone but also as an integral member of the team
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 Béatrice Stroobants:[email protected]
Our partner is looking for a GlobalQuality Lead Devices to reinforce its teams. Our partner is a well-known pharmaceutical industry.
Your responsibilities?
Design and development Quality assurance
Oversee Design & Development activities, from Inputs definition through Design Transfer (including Validation/Verification activities)
Review and approve relevant sections of the device design control documentation and/or Technical Documentation File as required
Review and approve protocols and reports for Verification & Validation studies, technology transfers, stability studies, etc…
Review and approve internal documentation. Ensure Design History File (DHF) is in place
Support Risk Management Activities related to devices. Ensure risk assessments are performed at appropriate stages of development/commercialisation and for decision making on issues arising.
Ensure deliverables are issued in accordance with the D&D plan
Review and approve submissions and responses
Vendor quality management
Accommodate design & technology transfer and ensure systems alignment between vendor and the company
Performing focused assessments/audits
Preparation and negotiation of Quality Agreements
Ensure systems alignment between vendor and the company
Facilitate quality improvement activities at vendors and company systems
Support risk register for the vendor, and follow up on mitigation activities
Monitor and trend vendor performance
Authority to accept release or block release of Medical Devices
Oversee inspection plans at CMO and the company
Quality processes
Facilitate investigations and resolution of issues relating to deviation and change management
Review and approve deviations
Lead/review critical investigations
Track CAPA events and closure
Oversee/track change controls
Your profile?
Minimum of 5 years working in the pharmaceutical/biologics/medical device industry in a quality management position.
Operational GMP experience or clinical activities experience would be a distinct advantage.
Practical understanding of ISO 13485:2016, MDR, ISO 14971 and 21CFR820 and part 4 requirements.
Should have a US and EU knowledge of pharmaceutical and medical devices regulations together with quality principles and techniques.
Take accountability for decisions and actions taken.
Be proactive, confident and enthusiastic during the interaction with colleagues during team work and take the initiative to promote and share/implement best practices.
Must possess good interpersonal, verbal, and written communication skills and be able to confidently present information at interdepartmental and external meetings. Ensure free flow of information throughout the sphere of work.
Root cause analysis and risk management/assessment skills will be a distinct advantage.
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.
Our partner is looking for an Analytical Methods Validation Bio to join its team. This international company is well-known for its pharmaceuticals and vaccines.
What are your responsibilities?
Within the Global Quality Control New Analytical Technology and Strategy department in close collaboration with local Quality Control sites around the world, you will participate to the identification, evaluation, and implementation of new or alternative analytical technologies to optimize Commercial Quality Control testing efficiency. Here are your mains tasks:
Organize benchmarking and technological watch to identify suitable analytical technologies focused on Automation.
Define plans for the evaluation of these new technologies and will lead the evaluation process by:
-Designing and organizing feasibility studies with the aim to confirm experimentally the expected theoretical benefit of the selected technology
-Designing and organizing proof of concept studies to confirm experimentally the suitability of the analytical method developed with the selected technology
Elaborate business case to demonstrate the economic benefits of investing and deploying this new analytical technology in the QC network.
Conduct experiments to support feasibility and proof of concepts studies to integrate new technologies on different QC sites
Closely interact with local QC sites across the network, quality, legal/IP and procurement partners
Who are you?
You hold a master’s degree in Biology/Biochemistry
You have a first experience in automation within the pharmaceutical industry
You have good knowledge in analytical techniques
You have good communication skills and are flexible
You are fluent (both written and spoken) 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 coordinator and Peptide Subject Matter Expert
Brabant Wallon – contracting
#Pharma #DS #API
Our partner is looking for a Project coordinator and Peptide SME to join its team. This international company is well known for the research, the development, and the commercialization of its pharmaceutical products.
What are your responsibilities?
The Project Coordinator Drug Substance and Subject Matter Expert (SME) will be responsible for the supervision and coordination of all external API activities. Here are your main tasks:
Represent technical DS during internal and external meetings and liaise with key stakeholders.
Functional representative (DS) in the Vendor Team as a CPR&D member
Co-develop and coordinate integrated functional project development and plans for DS and
consolidate project related work packages (internal and external) that are delivered
through the different departments
Integrate all aspects of DS, Biologics, and Analytical, to ensure that work packages (internal
and external) are initiated, executed and delivered to meet project timelines, milestones
and deliverables,
Identify, communicate, and manage risks associated with the assigned project and to
develop appropriate mitigations.
Proactively plan, track, drive all DS related activities and expenditures in their area of accountability ensuring full adherence quality and timelines ensuring any deviations are appropriately escalated.
Responsible for risk management for assigned project(s) within the function ensuring all major risks are identified, reported, escalated, and adequately mitigated
Ensure proactive and timely stakeholder management
Provide scientific leadership and project management for the assigned project based on phase of development and complexity.
Contribute to the coordination and review of relevant source documentation from technical function as required for filing/submission and actively support the registration processes.
Accountable for defining and implementing an integrated DS strategy in collaboration with SMEs functional line management and in alignment with the overall CMC strategy for assigned project(s).
Oversee Drug Substance development and manufacturing operations. Oversee process optimization, qualification batch manufacturing and process validation and coordinate the technical preparation for the PAI.
Proactively identify process issues and work collaboratively within the company and the CMO to address challenges.
Facilitate and support technology transfer activities at CRO/CMO.
Provide guidance to manufacturing, CMC and QA to ensure compliance with all applicable regulations and assist in resolutions of issues identified.
Identify and report deviations as appropriate, and typically work to resolve more complex deviations.
Responsible for authoring technical reports that are the basis of future CMC DS sections of regulatory dossiers and responsible for providing responses to regulatory inquiries.
Who are you?
You hold a PhD or a master’s degree with minimum 5 years of experience in a GMP environment
You have an experience in Late Stage of Development and/or in peptides
You are a good communicator and a team-player
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
You have experience in the qualification of lab equipment? You are autonomous and problem solver? Keep reading the description of your future job!
Our partner is currently looking for a Lab Support Coordinator. Our partner is an international pharmaceutical company.
What are your responsibilities?
As a Lab Support Coordinator, you will be working on a laboratory equipment obsolescence project. To be successful in this role, here are your main tasks:
Operational activities:
User requirement writer
Equipment decommissioning
Coordination activities:
Identify constraints
Planning dispatching
Link between operation & Project Manager
Presentation of results, constraints, next step of the planning
Who are you?
You hold a degree in a scientific domain. You have a relevant experience in the qualification of lab equipment. An experience in HPLC is a plus. You have experience in writing documentation (ex: URS, FAT, SAT, IQ, OQ). You speak fluently French and you have a professional English. You are a good communicator, autonomous and problem-solver.
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 Defruit, [email protected].
Our partner is looking for an Analytical Methods Validation to join its team. This international company is well-known for its pharmaceuticals and vaccines.
What are your responsibilities?
You will be the scientific analytical expert (physicochemistry) for the definition and deployment of the Continued Method Verification (CMV) program. Here are your main responsibilities:
Support project architect and participate in the elaboration of the overall project process steps, technical strategy and translate into deployment pilots (information gathering, build and propose scenario, present, and gather feedbacks, etc.)
Support QC sites in the deployment of CMV: identification of relevant test data, training on CMV tools and processes, Q&A, problem solving, …
Create/support the appropriate documentation to drive execution of the process steps, project execution
Collect and analyze the data produced and analyze the outcome in the context of the selected pilots of at the level of the overall project technical strategy
Participate in the definition of a program to be deployed according to pilot outcome.
Participate in the elaboration of the URS for the tools to be created
Participate in the design of a deployment strategy
Who are you?
You hold a master’s degree in sciences or equivalent by experience
You have a first experience of at least 5 years in the field of QC or analytical methods within the pharmaceutical industry
A strong interest in analytical data management is desired (database, data management system)
You have the ability to interact with statisticians and to work with data visualization tools
You are fluent (both written and spoken) 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
Commissioning and Qualification Projects Coordinator
Brabant Wallon – contracting
#Pharma #C&Q #IQOQ
Our partner is looking for a C&Q Projects coordinator to join its team. This international company is well-known for its pharmaceuticals and vaccines.
What are your responsibilities?
As a C&Q Manager, your role include:
Realize the planning of your qualification’s activities and integration in project global planning
Coordinate outsourcing activities involved in modification projects or qualifications activities
Include in all project meeting as user and Technical Support representative
Write TCD, IQO Protocols (mechanical and process control)
Execute or coordinate execution of IOQ Protocols (mechanical and process control)
Write IOQ Reports
Write and drives handover certificates and punch-list
Who are you?
You hold a master’s degree (Biology, Biochemistry, Chemical Engineering…)
You have at least 5 years of experience as a CQ Engineer within the pharmaceutical industry
You are an expert in the field of quality/validation/verification activities
You are a team player, disciplined and have strong communication skills
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
