Our partner is looking for a Qualification & Validation Engineer to join its team. This international company is well-known for its pharmaceuticals.
These positions aim to ensure the qualification and validation of production equipment, primarily for solid dosage forms and packaging.
Your responsibilities?
Qualification and validation of production equipment and installations
Cleaning validation within the scope of technology transfers and pharmaceutical development
Participation in process qualification optimization and continuous improvement
Support for various expansion and production capacity optimization projects
Interaction with production, maintenance, and quality assurance teams
Your profile?
5 to 8 years of experience in qualification and validation within the pharmaceutical industry
Knowledge of GMP regulations and best qualification practices
Strong experience in cleaning validation is highly valued
Skills in the qualification of packaging, assembly, and serialization equipment
Autonomy and ability to collaborate across multiple departments
Intermediate English level required for document reading and international supplier management
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.
En collaboration avec les RZ, RT et Coordinateur Santé Sécurité, au sein du département HSE :
Réaliser le suivi de chantiers sur le terrain (construction, rénovation, revamping, démolition, aménagement de nouveaux bâtiments et/ou bâtiments existants sur le site de Braine l’Alleud)
Réaliser des analyses de risques préalables (JRA) aux différentes phases de chantier
Réaliser les analyses d’incident et d’accident liés aux activités supervisées
Relire et superviser les PPSS & PGSS de chantier
Rédiger les rapports suite aux visites de chantier
Suivi des KPI HSE
Tisser les contacts nécessaires avec les personnes-ressource au sein de l’organisation et sous-traitance pour assurer le suivi de chantier
Votre profil :
Diplôme Bachelier
Min 3 ans d'expérience en matière de suivi de chantiers en tant que membre du département HSE (conseiller en prévention niveau 2) ou en tant que responsable de chantier.
Connaissance de la législation concernant la coordination santé sécurité des chantiers temporaires ou mobiles
Connaissance des risques fréquemment rencontrés sur un chantier, et en maitriser les mesures de prévention (travaux en hauteur, consignation, ATEX, manutention lourde, travail en espace confiné, utilisation de produits dangereux, utilisation d’engins et de machines-outils…) en vue de donner des avis éclairé en matière de sécurité
Connaissance et maitrise de la législation belge en matière Sécurité, Santé et Environnement (code du bien-être)
Être réactif et assertif face à toute situation dangereuse constatée – Avoir un excellent sens de la communication proactive et pouvoir ouvrir le dialogue afin de proposer des solutions pragmatiques en concertation avec la ligne hiérarchique
Notre offre : Jefferson Wells vous propose un contrat permanent en tant que consultant avec un package salarial attractif et vous donnera accès à des formations sur des sujets techniques ainsi que sur les soft skills. Nous serons votre partenaire de carrière à chaque étape de votre parcours. Vous êtes intéressé par ce poste ? Nous vous invitons cordialement à postuler ou à m'envoyer votre CV à l'adresse suivante : [email protected]
Département In vivo Pharmacologie – spécialisé dans les études in vivo, études de comportements sur différents rongeurs principalement souris et rats
Collectes de tissus, administration de composés et check effet sur le comportement des animaux
Préparation des réactifs et gestion du laboratoire
Votre profil ?
Master ou Doctorat en Sciences ou équivalent
Au moins un an d’expérience In vivo (meurins)
Titulaire du Felasa B
Connaissances en Excel
Excellentes compétences en Anglais
Notre offre ? Jefferson Wells vous propose un contrat permanent en tant que consultant avec un package salarial attractif et vous donnera accès à des formations sur des sujets techniques ainsi que sur les soft skills. Nous serons votre partenaire de carrière à chaque étape de votre parcours. Vous êtes intéressé par ce poste ? Nous vous invitons cordialement à postuler ou à m'envoyer votre CV à l'adresse suivante : [email protected]
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 the company 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/commercialization 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 the 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
Provide expert advice and support on operational and general QA activities for projects part of the devices portfolio (Process improvement, Technology Transfers, New products or life-cycle management…):
Act as the Operational QA link between selected external vendors within the Medical Device portfolio
Assist with regulatory and customer inspections at Vendors. Specifically focus on: Inspection preparation, Support during inspection, Support post inspection observation closure
Work closely with staff in the Corporate QA teams (especially CM&C Clinical Supply QA, Corporate Compliance and Affiliate Quality Services) and key Technical Operations teams/Affiliate teams to ensure that all QA services for selected critical vendors are provided in an effective and efficient way
Work in accordance with HSE and Corporate policy requirements and drive personal training and development activities to meet the needs of the business and professional career development
Support additional projects as requested
Provide on-site presence ‘in plant’ or on site at vendor
General GMP:
Maintain Quality System elements associated with the ISO, MDR and GMP activities in a compliant manner
Drive/Support projects related to quality system improvement
Maintain key performance indicators (metrics) for key operational development QA activities and services associated with the Medical Devices and Combination Products activities
Maintain GMP compliance and inspection/audit readiness at all times. Support Medical Devices QA in the inspection/audit preparation activities, during inspection/audit and for closure of inspection/audit observation with associated CAPA commitments
Support Medical Devices and Combination Products related inspections
Support Management Review Process
Support Design Reviews
Your profile:
Master’s degree in Sciences
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.
Fluency in French and in English
Practical understanding of ISO 13485:2016, MDR, ISO 14971 and 21CFR820 and part 4 requirements.
US and EU knowledge of pharmaceutical and medical devices regulations together with quality principles and techniques.
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]
Drive and promote a continuous quality and compliance mindset within Clinical Packaging & Logistics Operations, ensuring compliance with cGMP’s and the company Quality Management System
Partner with Clinical Supply Compliance Team and management to lead quality initiatives that develop and maintain a high performing, scalable, and compliant quality system in CPLO. Ensure close interface with QA, CS Compliance and CPLO teams.
Coordinate and/or participate in the implementation of new regulatory standards within CPLO processes.
Represent the interests of the CPLO teams, serve in multidisciplinary Compliance project teams, working closely with other team members in a cooperative way to ensure project progression
Coordinate and/or conduct Quality Standards Gap analysis for the CPLO processes, risk assessment, develop remediation plan and manage tasks to completion.
Consult and guide the teams in establishment of controls to mitigate compliance risk;
Oversee the CPLO GMP activities and ensure all employees understand and follow all standard operating procedures.
Works collaboratively with managers and staff throughout the CPLO organization to provide training, education and promote awareness of and help resolve regulatory and other applicable standards.
Assist management in the coordination/management of training plans & matrix and ensure compliance with staff qualification standard.
Participate in the development and implementation of compliance training for all CPLO staff members.
Provide compliance mentorship and coaching to staff within the CPLO team
Partner with CS Compliance to coordinate the audit/inspection preparation for CPLO. Timely and suitable Audit preparation (internal, Corporate or by the authorities), execution, support and follow up leading to successful outputs. On the front line during inspections.
Assist in ensuring inspection readiness, as well as participate in maintaining facility GMP compliance. Conduct self-inspections/housekeeping.
Analyze internal/external audit and other monitoring results with a view to identifying priorities for the further development of compliance actions.
Communicate, address and solve problems within own area of expertise as they arise, identifying and implementing innovative solutions to resolve them
Work closely with CPLO SMEs and QA teams to ensure deviations are adequately managed, according to the quality system guidelines and timely closed. Ensure adequate establishment of the root cause, product impact assessment, corrective and preventive action plan for CPLO. Be the investigation Power User for CPLO.
Provide support/coaching in quality system programs such as Deviation, CAPA, Change Control.
Assist management and staff in the writing of quality items such as Deviations, CAPA, Change Control, as well as writing of GMP documents relative to CPLO documentation to ensure compliance with all policies and procedures. Recommend, develop and implement changes to existing and proposed procedures.
Lead CPLO quality weekly meeting with management, SMEs and QA (Quality items review, SOP periodic reviews, training…). Participate in other CPLO TIER Meetings (QA, Prod…).
Ensure the management of the life cycle of CPLO logbooks. Perform routine logbook reviews
Ensure distribution of controlled documents to CPLO (Document distributor role).
Promote a culture of risk-managed, patient-centered, values-based, high performance and continually improve practice ensuring commitment to quality
Identify, lead and implement continuous improvement opportunities with the objective to streamline processes, increase productivity and quality (eg. optimization of cycle times, reduction of waste and reworks, improvement of Batch Record RFT….)
Develop and/or maintain KPI, tracking reports, scorecards, trending and other tools for monitoring the Quality System.
Ensure the daily follow-up of packaging activities:
Serves as the primary on-site point of contact for operators regarding operational matters, ensuring compliance support.
Refers managerial concerns (e.g., leave, training, conflict resolution) to the line manager for proper follow-up and decision-making.
Check with the manager to ensure that personnel are adequately trained and informed before performing any critical activities autonomously.
Inform management of issues encountered during packaging operations.
Record incidents in the quality system.
Ensure proper application of procedures (logbook, cleaning, packaging activities…).
Management and review logbooks
Distribute controlled documents for the CPLO (Document distributor role).
Provide support in writing investigations/deviations/CAPA related to packaging and labeling activities.
Distribute daily team work, monitor actual vs. theoretical throughput rates.
Participate in TIER meetings (Scheduling, QA, Prod…).
Participate in improvement initiatives for the Packaging Operations team (housekeeping, 5S, production efficiency, Batch Record Right-First-Time…).
Review production Batch Records.
Update performance indicators for the Packaging team.
Your profile:
Master’s degree in Sciences
Fluency in French and English.
Excellent understanding in GMP related environment : at least 5 years of experience in the pharmaceutical industry in the field of Manufacturing or Quality.
Proven and recognized expert in the field of GMP Compliance.
Expert dealing with with eCMS, Deviations and investigations.
Pragmatic mindset, able to propose workable operational solutions complying to regulations.
Proven ability to provide guidance for improvements and corrective and preventive actions related to quality management system processes
Ability to lead team discussions and facilitate meetings.
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]
Experience Cyber security and IT compliance/validation
Experience project Management and compliance
Experience qualification / validation process
Experience Data integrity concept and quality system
International experience a plus
Key technical backgrounds: small molecule chromatography (HPLC/UHPLC/GC) and detection techniques (UV/Vis, MS), electrophorese, USP/EP Pharmacopoeias, RMN, …
Mandatory skills: team player, exp. in a similar position/environment, compliant/rigorous
Fluency in French and 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. You’re interested in this job? We kindly invite you to apply or send me your CV, [email protected]
Your responsibilities: Part of the Development Quality Pharma Operational team, you 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).
You 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 to build the end to end “issued copy process’ for DEV/DSC entities.
Act as Reconciler by checking the correct completion of the “issued Copy” process,
Coordinate the development local instructions, liaise with dev key stakeholders in order to maintain common practices with regards to “issued copy” within development entities” ensuring appropriate application of the “issue copy process.”
Provide support during regulatory inspections, and quality improvement initiatives. You will contribute the preparation of audits (internal/external, regulatory inspections )
Provide guidance and expert advice to development scientists, particularly with regard to the appropriate interpretation of national and international GMP regulations and guidelines
Identify, mitigate and subsequently resolve compliance and quality issues that may affect the 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.
Support QA activities for all Dev QA entities ( Lab, pilot plant,…..)
Maintain and continuously improve Quality systems and processes in place for the appropriate documentation of the company development activities and ensure compliance with regulatory and corporate requirements.
Partner with QA and CMC Development/DCS 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 data integrity and compliance with regulatory requirements and industry best practices
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
Lead the GMP refresher project for CSC and Lab entities
Your profile:
Master’s or bachelor’s degree in a relevant field (e.g., Life Sciences, Engineering, or Quality Management).
Minimum of 3 years of experience in data integrity and documentation control within the biopharmaceutical industry.
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.
QA/compliance experience in DS/DP/IMP manufacturing, facility operation, laboratory compliance and quality systems is an asset.
Fluency in French and English
Must be able to act in most circumstances without direct supervision and handle complex/difficult situations. Output from actions will most likely impact activities across several departments
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]
Promote Quality and Operational Excellence and cultivate “Quality Culture”, “Compliance Awareness”, “Continuous Improvement Attitude” & “Accountability Culture” across the UCB teams.
Drive Quality Leadership on Quality & Compliance Strategy and interact with other functional areas to effectively communicate system & process requirements.
Maintaining and continuously improving the Quality Management System and related processes.
Ensuring continued compliance of the QMS to applicable regulations and guidelines, the company Corporate Policies & Procedures, objectives, plans and projects.
QA Systems Officer on Utilities, HVAC & Cleanroom Systems & Operations:
Using a Risk Based Approach, ensure that all Utilities, HVAC & Cleanroom Systems used by the campus and related supporting services are compliant with applicable regulations and guidelines (EMEA, FDA, PIC/S, ICH, best practices as defined by relevant organizations) and the company Corporate Policies & Procedures.
Cultivate a “Compliance Awareness Culture” across the manufacturing department and related supporting services.
Ensure communication of compliance status and issues to the appropriate levels of the organization
Ensure a relevant cGMP level regarding subcontractors used to support routine operations for the Braine Manufacturing site and its supporting services.
Participate in the preparation for regulatory inspections and provide direct support to System Owners and main customers during inspections.
Support the System Owners to develop and implement technically robust and compliant Systems allowing to continuously improve their operations.
Responsible for all cGMP aspects related to the Utilities, HVAC & Cleanroom Systems owned by the System Owner.
Drive quality leadership and technical expertise on Utilities, HVAC & Cleanroom Systems compliance strategy and interact with other functional areas to effectively communicate System requirements.
Encourage and assist in the development of remediation and mitigation plans for Utilities, HVAC & Cleanroom Systems & Projects to ensure that they meet policies, procedures, and regulatory requirements.
Establish and/or assist in the establishment of policies, procedures and standards for the company consistent with pertinent government regulations and procedures.
Assure that the Utilities, HVAC and Cleanrooms operate in accordance with the company Quality Standards and applicable national and/or international regulations and guidelines (EMEA, FDA, PIC/S, ICH)
Together with the Utilities, HVAC & Cleanroom System Owners, ensure direct follow of Compliance Audit activities, Deviations, Planned Deviations, Failure Investigations and Change Control related to the Utilities, HVAC & Cleanroom Systems
Ensure cGMP training related to Utilities, HVAC & Cleanroom activities
Ensure follow-up and communication to QA Manufacturing teams of Deviations, Planned Deviations and Change Control related to Utilities, HVAC & Cleanrooms that could have an impact on manufactured batches
Support the Qualification & Validation activities for Utilities, HVAC & Cleanrooms and perform QA approval and QA authorization of related documentation.
Your profile:
Master Degree in engineering or sciences preferred
Experience in a regulated pharmaceutical environment or other life science or health related field is mandatory
Fluent in French, very good level in English is required
Affinity for Quality & Compliance and worldwide regulations pertaining to cGMP regulations pertaining to Pharmaceuticals & Medical Devices
Team player with good interpersonal relationship and communication 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 or send me your CV, [email protected]
Your responsibilities: As a part of the Internal Bio & GT Manufacturing Systems Quality Team, you will:
Work closely with Clinical Manufacturing Teams 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.
More specifically, provide quality support for qualification and validation activities related to Clinical Manufacturing activities like facilities cleaning processes, viable and non-viable environmental monitoring, equipment and system qualification/validation
Drive the continuous QA improvement process. Ensure adequate documentation processes and systems are available and followed for development projects (SOPs / Protocols / Report review…)
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 the company development activities and products.
Support Change Control and perform the QA evaluation
Ensure KPI (including extracts) are adequately maintained and Shared.
Ensure Issued Copy document are following the issued copy and reconciliation process
Your profile:
Master’s degree in Sciences
Fluency in French and English
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.
QA/compliance experience in DS manufacturing, facility operation, laboratory compliance and quality systems are an asset.
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
Ability to work autonomously for the assigned activities with limited supervision
Must be able to act in most circumstances without direct supervision and handle complex/difficult situations. Output from actions will most likely impact activities across several departments
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]
Vos responsabilités : Dans le cadre d’un projet BBOC+, le Quality SME est en charge :
d’un package d’équipements / systèmes dont il/elle est responsable de :
S’assurer que les requis GMP soient intégrés dans le design des équipements / systèmes.
Participer au processus de sélection des vendeurs.
Assurer un oversight qualité tout le long de la phase de construction / installation / mise en service.
Développer les procédures permettant leur utilisation et leur maintenance.
Assurer le release avant utilisation GMP.
S’assurer du respect du timing et de la qualité et aider au respect des budgets.
d’un ensemble de processus qualité (Engineering) dont il/elle est responsable de :
S’assurer que les procédures sont à jour.
S’assurer que la stratégie de training soit définie.
S’assurer de la correcte implémentation tout au long du projet
de groupes de travail liés à l’intégration de la phase d’extension avec les processus actuels du B7 dont il/elle est responsable de :
Définir le scope et les membres (core team et ad-hoc team).
Leader les discussions du groupe de travail pour dérouler le plan d’action.
Assurer un reporting adéquat.
Votre profil :
Master’s degree in Sciences
Minimum 8 ans d’expérience en production / qualité dans le domaine biotechnologique.
Bonnes connaissances des requis règlementaires biotech.
Bonne habilité à challenger et à défendre ses opinions.
Parler Français et Anglais couramment
Notre offre : Jefferson Wells vous propose un contrat permanent en tant que consultant avec un package salarial attractif et vous donnera accès à des formations en compétences techniques et en soft skills. Nous serons votre partenaire de carrière à chaque étape de votre parcours. Vous êtes intéressé par ce poste ? Nous vous invitons à postuler ou à m'envoyer votre CV à l'adresse suivante : [email protected]
