Operations Quality Partner Contracting – Walloon Brabant Your responsibilities?
Work closely with Internal Bio Clin Manufacturing Team to ensure that the Quality Management System in support of product development and clinical supplies, work in a way that ensure product quality, safety and efficacy, meet regulatory requirements and expectations and operate in a fit for purpose and in a smarter way.
Ensure quality review of master and executed batch records for drug substance supporting clinical trial studies
Release of materials used in production of drug substance for clinical trials
Drive the continuous QA improvement process. Ensure adequate documentation processes and systems are available and followed for development projects (SOPs / Protocols / Report review /approval Tech Transfer).
Plan and manage compliance tours and on the floor spot-check of the GMP area, offering quality assurance support including but not limited to inspection.
Be partner with other departments to identify, mitigate and subsequently resolve compliance and quality issues (Investigations / deviations / out-of-specifications) that may affect development activities and products. – Support Change Control and perform the QA evaluation
Provide quality support for qualification and validation activities related to Biotech Sciences activities
Your profile?
QA/compliance experience in DS manufacturing, facility operation, laboratory compliance and quality systems is an asset.
A good understanding of current regulatory requirements and expectations and an ability to interpret current regulations and requirements in the product development context is essential.
Good background knowledge of the pharmaceutical biologics industry and applicable technical aspects of the Business
Understands practical applications of GMP, compliance principles and theories including risk management
Good written/oral communication in English
Ability to work autonomously for the assigned activities with limited supervision
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. Do you have any questions? You can contact Anaïs Malikian, [email protected]
This global position as SAP System Quality Support will provide secondment to the main SAP System Quality Partner to deliver major projects linked to SAP PE1, more specifically linked to the Quality and Batch Management Modules. The goal will be to link business needs and IT constraints, to deliver lean processes within the modules and ensure sustainability through E2E testing. The function will provide QA expertise supporting continuous improvement such as reworking, standardization and alignment of processes; but also writing of procedures, trainings and coaching of local key users.
The Responsibilities The SAP System Quality Support for Quality and Batch Management function in alignment with and under the guidance of the main SAP System Quality Partner will:
Link business needs and IT constraints in projects, to deliver lean processes within the modules.
Provide expertise in the modules to improve as much as possible including revamping, standardization, and alignment of processes; writing of procedures, trainings and coaching of local key users who will train End Users.
Support incidents investigation, correction, and related improvements to be done in the systems as part of Day-to-day routine activities with IT and business entities.
Ensure requested development to IT are matching business requirements by testing in depth new functionalities in systems.
Ensure to keep the tool sustainable in order to be also able to support deployment of system upgrades.
Help developing a community around the SAP System Quality team, which can be split into two parts: Community across Key users linked to SAP Improvement Project but also community within the module’s QM and BM with related LKUs (local key users).
Skills and Knowledge Requirements
Master’s degree required.
Strong Knowledge of SAP system preferably in Quality Management; HPALM knowledge is an asset.
Must be able to communicate (write/speak) fluently in English (communication with IT outsourced), French is an asset.
Analytical mind-set with a capacity to see the bigger picture.
Negotiation skills.
Strong written and oral communication skills.
Self-driven, results-oriented with a positive outlook and a clear focus on high quality
Fast learner.
The candidate will need to be able to strongly defend Quality and standardization of the processes within the modules by negotiating, analyzing the details while seeing the bigger picture and by ensuring business and IT satisfaction.
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. Do you have any questions? You can contact Aylin Ugurlu at [email protected]
Notre client est à la recherche d’un nouveau SME (Subject Matter Expert) Qualification / Validation dans le cadre de la mise en production de nouveaux systèmes, procédés et équipements GMP informatisés ou non informatisés. La personne aura pour objectif de définir et proposer la stratégie de qualification / validation pour les systèmes, procédés et équipements. Cela comprend :
Réalisation/Animation des analyses de risques qualité.
Définition de la stratégie de qualification / validation en accord avec l’équipe projet.
Rédaction du plan de validation et des documents de qualification associés.
Mettre en place une approche efficace et standardisée de qualification et de validation des systèmes, procédés et équipements.
Rôle et Responsabilités
Développer un partenariat avec les clients internes, les services support internes (IT, Métrologie, Contrôle périodique) et les fournisseurs externes.
Prendre en charge les projets de qualification / validation des systèmes, procédés et équipements qui lui sont confiés dans le respect des planning définis :
Coordination et suivi des activités de qualification / validation confiées
Elaboration de la stratégie de qualification / vérification / validation
Rédaction des documents de qualification / validation
Coordination / exécution des tests
Attribution du statut qualifié aux équipements
Attribution du statut validé aux procédés
Réaliser les Periodic Reviews des systèmes et équipements qui lui qui lui sont confiées :
Coordination des « Periodic Review » sous sa responsabilité
Etre garant du respect du planning de « Periodic Review » (Requis Compliance)
Ré-évaluation du statut qualifié des systèmes et équipements
Rédaction des rapports GMP et QUALITE : Travailler en collaboration avec le Service « Quality Assurance » pour assurer la conformité vis-à-vis des réglementations en vigueur, guidelines, normes et procédures internes (SOP).
Participer aux audits internes, audits externes et Inspections réglementaires (autorités nationales, internationales, FDA, EMEA, etc…).
Reporter à sa hiérarchie tout problème ayant un impact sur la qualité des systèmes, des instruments ou des produits fabriqués et/ou en développement.
Qualifications et compétences requises.
Bachelier ou master dans un domaine relevant au poste.
Minimum 3 à 5 d’expérience dans le scope d’activités.
Une expérience solide en qualification et validation d’équipements.
Une expérience dans le secteur pharmaceutique.
Avoir déjà mené à bien un projet en rapport avec la qualification/validation.
Notre Offre A la recherche d’un nouveau défi professionnel ? Jefferson Wells vous offre un accompagnement, étape par étape, pour l’accomplissement de votre prochain objectif professionnel. Un contrat en CDI ou une collaboration avec Freelance possible. Une question ? Un doute ? Ou tout simplement intéressé-e par le poste ? Contactez Aylin Ugurlu : [email protected] .
Dev Quality Lab Ops Partner Contracting – Walloon Brabant
Your responsibilities ? Part of the Clinical Manufacturing Quality team, the candidate will ensure the establishment, implementation, maintenance, and continuous improvement of an effective Quality Management System (QMS) linked to product development for:
The GMP oversight of different laboratories and production pilots, including packaging, and outsourcing
The GSP oversight (non- GMP activities) of different development entities, located on the Braine site (BE), the Slough site (UK) and the Monheim site (DE).
The Candidate will also :
Drive continuous quality improvement process, ensuring that the Quality Management System in support of product development and clinical supplies, work in a way that ensure product quality, safety and efficacy, meet regulatory requirements and expectations and operate in a fit for purpose and in a smarter way.
Provide support for qualification and validation activities of the different laboratories and production pilots.
Provide support during regulatory inspections, and quality improvement initiatives. You will contribute the preparation of audits (internal/external, regulatory inspections).
Identify, mitigate and subsequently resolve compliance and quality issues that may affect company development activities and products. These lessons learned, once implemented, shall then form the basis for future cross functional and cross project training and improvement opportunities.
Ensure adequate QA support for the qualification, validation and maintenance of the equipment, classified rooms, HVAC used in development manufacturing areas or laboratories, as well as related cleaning validations.
Train company personnel regarding cGMP/GSP and QMS requirements related to manufacturing and analytical operations for clinical trials and stability studies.
Manage Quality Assurance Agreement for New and On-going Supplier.
Adjust the Level of Quality and associated procedures based on changing regulatory requirements, technical and scientific knowledge.
Implement and maintain a quality risk management process for the systems used in Development.
Maintain and continuously improve Quality systems and processes in place for the appropriate documentation of company development activities and ensure compliance with regulatory and corporate requirements.
Partner with QA and CMC Development/CTS colleagues to identify and mitigate Compliance risks, resolve potential regulatory observations.
Implement and maintain adequate Quality & Compliance Indicators and communicate results to appropriate levels of the organization.
Manage Quality meetings to maintain adequate level of compliance of the business activities.
Ensure and maintain the adequate accreditation for all laboratories (in /out Braine).
Proactively support the activities of Development Quality Lead for relevant laboratory/manufacturing quality systems (deviation close out / change management/ complaints/ quality improvement).
Ensure Development Quality Management System directly support Technical Operations and development partner goals and objectives.
Coordinate the local development process for supplier qualification, maintain the training material associated to it, act as facilitator in order to ease the supplier qualification exercises for development activities, act as enabler and support business partners in order to ease the process, ensure operational qualification of development suppliers. Ensure all information available in the different database are up to date, manage the Change notification from suppliers and coordinate assessments with impacted stakeholders, maintain documentation up to date.
Coordinate and execute the development management review, ensuring principles mentioned in the associated corporate procedure are fulfilled for development entities.
Coordinate the development local instructions, liaise with dev key stakeholders in order to maintain common practices with regards to internal audit within development entities, coordinate and update the development internal audit schedule, ensuring appropriate application of the audit planning and also manage Self inspections in the Lab.
Act as Vendor Quality Lead back up for on Quality Oversight.
Your profile ?
Project Management Skills (tools like MS Project).
Technical Knowledge in engineering, particularly in pharmaceutical production (secondary packaging and medical devices).
Strong Communication Skills, including experience leading meetings and coordinating between teams.
Experience in IT and Automation (networking, IT security, data integrity).
Autonomy, the ability to manage multiple projects simultaneously under pressure.
Proficiency in French (essential for communication with production) and English (professional level required for international communication).
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. Do you have any questions? You can contact Caroline, [email protected]
Pharma Process Engineer Contracting – Walloon Brabant
Your responsibilities ?
Project Management: Coordinate a portfolio of projects (mainly in secondary packaging and medical devices), ensuring proper management of schedules and critical milestones.
Inter-project Coordination: Link technical teams, production, and experts (IT, automation) across different departments.
SME Support: Provide technical expertise as needed in engineering and processes, especially in IT, data security, and automation.
IT/Automation Project Oversight: Manage projects related to Data Integrity, IT security, and the automation of manufacturing facilities.
Your profile ?
Project Management Skills (tools like MS Project).
Technical Knowledge in engineering, particularly in pharmaceutical production (secondary packaging and medical devices).
Strong Communication Skills, including experience leading meetings and coordinating between teams.
Experience in IT and Automation (networking, IT security, data integrity).
Autonomy, the ability to manage multiple projects simultaneously under pressure.
Proficiency in French (essential for communication with production) and English (professional level required for international communication).
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. Do you have any questions? You can contact Caroline, [email protected]
‘Global Quality Auditing Outsourcing R&D Lead’ implements a Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) audit strategy, including delivery of a risk-based audit program covering the quality and compliance of the GCP/GLP Quality Systems. The incumbent is by this means ensuring that clinical trials are managed in compliance with regulatory requirements, contractual agreements, as well as company’s Global Quality Management System; and that compliance risks are appropriately identified and mitigated.
The Responsibilities
1. External Auditing vendor management
Support vendor management involved in R&D audit activities and ensure compliance with regulatory requirements.
Play a key role to assist in defining, evaluating, and monitoring key performance indicators (KPis) and drive key quality indicators (KQis) for R&D auditing vendors, and assisting with continuous improvement initiatives relating to management of vendors.
Review and/or approve required Auditing Documents related to the activities in scope.
Prepare, support and follow-up on R&D (GCP and/or GLP) audits performed on behalf of the company by external vendors, as per established process, contracts, and procedures. Ensure that execution of outsourced audits is conducted and completed in alignment with internal audit processes and standards. This also includes the appropriate oversight of vendors performing audits on behalf of the company.
As required, provide management with a summary and analysis of quality risks and outcomes related to Auditing vendors activities.
2. External Auditing:
Contribute and/or participate in the development of the risk based GLP/GCP audit program through evaluation of elements of the internal quality system and their effect on the overall state of compliance of the system.
Perform GCP and/or GLP audits as per annual audit program (investigator sites, vendors, systems, … according to established audit strategy).
Perform GCP and/or GLP audits of potential new vendors/partners for purposes of qualification prior to contractual relationships.
Proactively manage findings, responses and CAPAs arising from audits in the Audit Management Tool, using all reasonable efforts to obtain prompt mitigation of deficiencies by responsible functions/persons and escalating concerns as required to senior management.
Support the preparation, hosting and follow up of critical Regulatory Authority inspections related to clinical activities, in collaboration with the R&D and PV Quality team.
3. Drive Insights for UCB through Data:
Ensure timely and accurate input of audit data in Audit Management Tool.
Contribute data and feedback to GCP/GLP-relevant internal stakeholders in UCB (e.g. Global Clinical Science and Operations, Global Clinical Development, Development Rare Disease, etc.) relating to Key Quality/Performance Indicators and quality compliance status.
4. Compliance Issues:
Through active participation to several forums and through direct interaction with colleagues, escalate concerns and provide expert guidance on GCP/GLP compliance issues to support the development and implementation of necessary CAPAS and quality improvement measures.
Escalate Critical Compliance risks/issues to Global Quality Auditing Leadership.
5. Consulting, Educating, Quality Improvement, and External Focus:
Utilize in-depth knowledge and understanding of current business trends, applicable regulations, and quality principles, to collaborate effectively and influence approaches to quality, and ensure work products and output are aligned with regulatory guidelines, ICH/GCP, GLP regulations, other applicable regulatory requirements, and the company global quality standards.
Participate in medium-long term projects within competence.
Upon the request of/with the approval of Global Quality Auditing Leadership, perform other tasks within competence (as determined by relevant training, experience and/or qualifications).
The Skills and Knowledge Requirements
Substantial and broad-ranging experience in the pharmaceutical/biotechnology area including significant time working in GCP/GLP related areas.
3 years’ experience in leading full range of GCP audits for internal processes/units and external partners or vendors, with depth of understanding of the theory and practice of quality management.
Experience in the pharmaceutical/biotechnology area including time working in GLP and/or GCLP-related areas.
Minimum of 3 years of auditing and 5 years overall dealing with research and development area. Experience in vendor management is a plus.
In-depth knowledge and understanding of ICH-GCP, applicable regulations (domestic and international), quality principles, relevant business processes and techniques. Able to apply theoretical knowledge in practical situations.
knowledge and understanding of Human Tissue Act and the Human Tissue Authority (HTA) codes of practice, GLP, GCLP, Good Research Practices and their applicable regulations (domestic and international), quality principles, relevant business processes and techniques.
Fosters a quality culture of shared accountability and knowledge sharing through inspiring, motivating, influencing, teaching and coaching others.
Knowledge regarding the use of electronic systems in a regulated environment, and personal functional computer literacy
High level of personal integrity with a strong commitment to patient welfare and ethical behavior.
Fluent in written and spoken English. Additional language skills would be an advantage.
Able to travel nationally and internationally as business necessitates,20% of time on average.
Demonstrated self-starter, highly reliable, with positive, action oriented, enthusiastic approach, ability to manage own workload, set priorities within the remit allocated by management and willingness to accept responsibility.
Confident presenter and communicator, able to give presentations to interdepartmental audiences and represent company with externals and deliver clear verbal and written messages in a constructive and effective manner to a variety of audiences/recipients.
Skilled negotiator, able to influence and obtain cooperation from colleagues, business partners and other stakeholders, including senior management during audit process.
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. If you are interested, you can send your CV to [email protected] .
To evaluate the feasibility and risk associated with Capital Investment (CAPEX) projects.
To relay customer consideration and take benefit of his expertise in the definition of requirement (URS) and the solution design.
To ensure the management of the supplier until the FAT, SAT and commissioning.
To support the qualification according to company SOPs and ICH guidance.
When applicable to organize the process technical transfer.
This includes:
To elaborate the technical transfer strategy and to prepare/review of the test protocols. The input should be based on the coordinator’s technical background and the knowledge of the equipment to define a plan technically feasible and acceptable on GMP aspect.
To coordinate support departments (RA, QC, QA, Qualification/Validation, Development, Technical Services, Industrial IT, Supply Chain, HSE, Metrology, Sourcing, Facility, Finance, Utilities…) for projects implementation.
To prepare the equipment and to program the recipes on manufacturing equipment.
To ensure that the equipment runs properly and if needed to connect with supporting services (maintenance, IT and external supplier/service providers).
To deliver to the client the technological know-how capitalized during commissioning and qualification campaign.
To support the client department for pre-approval inspections of delivered new equipment and processes.
To identify, propose and implement technical solutions to improve plant capacities, to reduce COGS, to increase efficiency and improve Quality compliance.
To supervise the strict application of Safety & Hygiene rules and foster development of improved practices.
Skills and Knowledge Requirements
Knowhow in automation, packaging, and medical devices technologies
Senior experience on Project management methodology.
Prioritization skills and ability to successfully manage multiple tasks simultaneously.
Teamwork: ability to work well in highly cross functional and inter-site team environment.
Communication skills: ability to express clearly and concisely within a team. To adjust communication style for the audience. To timely and effectively communicate on issues.
Technical writing skills to support authorship of internal documentation.
Knowledge sharing: ability to capture and to digest information from multiple sources and to build intelligible knowledge to be shared with project clients.
Knowledge of GMPs
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. Do you have any questions? You can contact Aylin Ugurlu at [email protected]
Manages Non-clinical formulation activities related to the screening and CMC development of small molecule, peptide or other synthetic drug products (from discovery and preclinical stages to clinical formulation orientation work for First-In-Human). Typical formulations are microsuspensions, amorphous solid dispersions, and nanosuspensions.
Liaises with Non-Clinical formulation Leads to assure consistency between the development and the production of NCL formulation, and the project needs.
Manages protocols of development or production and participate to the planning of activities.
Participates to the development, characterization, and production of non-clinical formulations.
Performs the physico-chemical characterization and stability studies of new molecules (NCEs) on batches before the GLP batch. Typical characterization techniques are liquid chromatography (UPLC), thermal analysis (DSC, TGA), laser diffraction granulometry, optical and electron microscopy. Develops if needed new methods.
Analyses results with readiness to criticize and ensures the consistency of these results with earlier data if relevant.
Documents and verifies in an appropriate manner the whole of the performed activities (e.g. Electronical Lab Notebook)
Consolidates the results and write adequate reports.
Contributes to the writing of technical documents like SOPs, user guides, guidances, etc.
Participates to the advancement of the department’s Science & Technology and Innovation projects The scientist needs to be autonomous and think pro-actively, in collaboration with the Non-Clinical formulation lead. The need to already have an experience in formulation with a preference for Non-Clinical formulation development, with knowledge in the related analytical support. He needs to be flexible, well-organized, curious and have good communication and coaching skills. He needs to be able to combine multiple tasks and must adapt to priority changes.
Skills and Knowledge Requirements
Master/PhD: pharmaceutical sciences, formulation, analytical chemistry or equivalent
Min years’ experience required: 2-3 years in formulation domain, preferentially in non-clinical formulation field.
Key technical backgrounds: non-clinical formulation preparation, small molecule chromatography (HPLC/UHPLC)
Mandatory skills: team player, communicative, experience in a similar position/environment, compliant/rigorous, flexible, curious
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.
Analytical Development Analyst Contracting – Walloon Brabant
Your responsibilities ? Operational :
Develop and validate analytical methods to support projects in development in different phases of product development.
Perform analyses of raw materials, intermediate products, in bulk or pakaged finished products in accordance with work instructions and established procedures (stabilities, in-process control, clinical release, investigation, …).
Ensure stability analyses and clinical release for clinical phases I and II, as well as any analyses in support to process understanding (IPC test, forced degradation study, multimedia dissolution, …)
Analyze results with readiness to criticize and ensures the consistency of these results with earlier data if relevant.
Participate to analytical exercise transfer to QC and subcontractors.
Monitor the documentation associated with the analytical laboratory activities by mastering the computer softwares in use at the laboratory (eg Mikado, GLIMS, e-noval, TrackWise, …).
Quality :
Make sure to have received and understood all the information and instructions required for the tasks before starting work.
Respects the procedures and reports any discrepancies to the responsible
Use authorized and validated methods prior to testing, if applicable.
Respect and properly maintain the analytical equipment and facilities at disposal.
Performs double check the team
Your profile ?
Master or Bachelor: analytical chemistry
Key technical backgrounds: small molecule chromatography (HPLC/UHPLC/GC) and detection techniques (UV/Vis, MS), USP/EP Pharmacopoeias
Mandatory skills: team player, exp. in a similar position/environment, compliant/rigorous (understands the importance of following procedures in detail)
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. Do you have any questions? You can contact Caroline, [email protected]
Ce poste fait partie de l'équipe Supply et logistique. Les membres de l’équipe Supply assurent l’approvisionnement en matières et matériel afin d'assurer les activités GMP et non-GMP. La principale responsabilité sera la gestion des Specification et des Change Notification pour les produits biologiques et les thérapies géniques.
Responsabilités
Assurer la création et la mise à jour des spécifications / FIP et des documents associés (TSE/BSE, Certificats…) pour les matériaux et consommables utilisés en collaboration avec les laboratoires et les ingénieurs process.
Évaluer/documenter les Change Notification de la Pharmacopée ayant un impact potentiel sur les produits utilisés et mettre en œuvre des actions si nécessaire.
Gérer l’évaluation des notifications de changements des fournisseurs pour les matières premières et définir des actions associées.
Participer activement au système de gestion des déviations (ouverture de PR, investigations, CAPA, Change control…) et s’assurer de leur réalisation en temps et en heure
Gestion logistique des vêtements nécessaire au bon déroulement des activités GMP et le suivi du fournisseur associé
Participer aux activités de sécurité
Connaissances et Expériences Requises
Esprit organisé et systématique
Excellentes compétences en communication, dans la mesure où vous interagissez avec différentes équipes/parties prenantes : opérateurs, responsables de la production, équipe de validation, QA.
Esprit d'amélioration continue.
Maîtrise du français et bonne connaissance de l'anglais
Notre Offre Si vous êtes passionné(e) par l'innovation et que vous souhaitez contribuer à un projet stimulant au sein d'une entreprise de renommée mondiale, postulez dès aujourd'hui à notre offre. Jefferson Wells s’engage à vous offrir un contrat en consultance, un accompagnement rapproché ainsi qu’un salaire et un package attractifs. Des questions ? Vous souhaitez soumettre votre candidature ? Envoyez un mail à [email protected] .
